MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number ATG80164

Device Problems Break (1069); Deflation Problem (1149); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 08/08/2018

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that during an angioplasty procedure for a chronic lesion in the brachiocephalic vein, the physician allegedly had difficulty positioning the balloon for inflation.The pta balloon was inflated 6 to 8 atm with a 20 ml syringe; although blood return was identified during the first inflation.Guided fluoroscopy demonstrated the proximal end of the balloon became detached from the catheter.The physician stated that after several unsuccessful attempts made to deflate the balloon, guided fluoroscopy demonstrated complete balloon detachment without migration from the system.The patient was transferred to another hospital for the removal of the pta balloon.The interventional radiologist was able to snare the balloon via femoral vein access and advanced it to the access sheath; however, the balloon could not be deflated or removed over the wire.The patient was taken to surgery for a cut down procedure for successful removal of the pta balloon.The patient was reported to be hemodynamically stable at the conclusion of the procedure.

Event Description

It was reported that during an angioplasty procedure for a chronic lesion in the brachiocephalic vein, the physician allegedly had difficulty positioning the balloon for inflation.The pta balloon was inflated 6 to 8 atm with a 20 ml syringe; although blood return was identified during the first inflation.Guided fluoroscopy demonstrated the proximal end of the balloon became detached from the catheter.The physician stated that after several unsuccessful attempts made to deflate the balloon, guided fluoroscopy demonstrated complete balloon detachment without migration from the system.The patient was transferred to another hospital for the removal of the pta balloon.The interventional radiologist was able to snare the balloon via femoral vein access and advanced it to the access sheath; however, the balloon could not be deflated or removed over the wire.The patient was taken to surgery for a cut down procedure for successful removal of the pta balloon.The patient was reported to be hemodynamically stable at the conclusion of the procedure.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.However, two radiopaque images were provided for review.Based on the image review, the returned images suggest balloon separation from the catheter at the proximal balloon weld location.However, a complete detachment of the balloon could not be confirmed.Therefore, the investigation is confirmed for a break at the proximal balloon weld.However, the investigation is inconclusive for the reported detachment as it is unknown if the entire balloon is detached from the catheter.Also the investigation is confirmed for the reported deflation issue, as the images show contrast within the balloon.However, the investigation is inconclusive for the reported unintended movement of the balloon during inflation, as this could not be identified based on the image review.It is possible that a deflation issue could lead to balloon detachment, as the balloon would be drawn into the introducer sheath.However, the definitive root cause for the deflation issue, weld break, or the reported placement issues at the lesion could not be determined based on the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date: 04/2021).(add trending device code: 3026 - unintended movement).

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.However, two radiopaque images were provided for review.Based on the image review, the returned images suggest balloon separation from the catheter at the proximal balloon weld location.However, a complete detachment of the balloon could not be confirmed.Therefore, the investigation is confirmed for a break at the proximal balloon weld.However, the investigation is inconclusive for the reported detachment as it is unknown if the entire balloon is detached from the catheter.The investigation is also inconclusive for the reported rupture as it could not be determined if the balloon ruptured, based on the images provided.The investigation is confirmed for the reported deflation issue, as the images show contrast within the balloon.However, the investigation is inconclusive for the reported unintended movement of the balloon during inflation, as this could not be identified based on the image review.It is possible that a deflation issue could lead to balloon detachment, as the balloon would be drawn into the introducer sheath.It is also possible that a deflation issue could be the result of a rupture and/or detachment.However, the definitive root cause for the deflation issue, weld break, or the reported placement issues at the lesion could not be determined based on the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: b5, d4 (expiry date: 04/2021), g4, h6(device: 3026, 1546) h11: g1, h6(patient) h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that during an angioplasty procedure for a chronic lesion in the brachiocephalic vein, the physician allegedly had difficulty positioning the balloon for inflation.The pta balloon was inflated 6 to 8 atm with a 20 ml syringe; although blood return was identified during the first inflation.Guided fluoroscopy demonstrated the proximal end of the balloon became detached from the catheter.The physician stated that after several unsuccessful attempts made to deflate the balloon, guided fluoroscopy demonstrated complete balloon detachment without migration from the system.The patient was transferred to another hospital for the removal of the pta balloon.The interventional radiologist was able to snare the balloon via femoral vein access and advanced it to the access sheath; however, the balloon could not be deflated or removed over the wire.The patient was taken to surgery for a cut down procedure for successful removal of the pta balloon.The patient was reported to be hemodynamically stable at the conclusion of the procedure.New information: it was reported through the litigation process that during an angioplasty of av fistula, the pta balloon allegedly ruptured, detached, and became dislodged in the patient.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.However, two radiopaque images were provided for review.Based on the image review, the returned images suggest balloon separation from the catheter at the proximal balloon weld location.However, a complete detachment of the balloon could not be confirmed.Therefore, the investigation is confirmed for a break at the proximal balloon weld.However, the investigation is inconclusive for the reported detachment as it is unknown if the entire balloon is detached from the catheter.The investigation is also inconclusive for the reported rupture as it could not be determined if the balloon ruptured, based on the images provided.The investigation is confirmed for the reported deflation issue, as the images show contrast within the balloon.However, the investigation is inconclusive for the reported unintended movement of the balloon during inflation, as this could not be identified based on the image review.Per the reported event details, the user was attempting to perform an angioplasty in the brachiocephalic vein while utilizing a 7fr sheath.Per the product labeling this device size is to be used with a 8 french sheath size at a minimum.The instructions for use states "do not attempt to pass the pta catheter through a smaller size sheath introducer than indicated on the label." it is possible that the smaller than acceptable sheath size contributed to the reported issues.A deflation issue can lead to removal issues through the sheath and possibly balloon detachment, as the balloon needs to be fully deflated prior to drawing into the introducer sheath.However, the definitive root cause for the deflation issue, weld break, or the reported placement issues at the lesion could not be determined based on the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 04/2021), g4, h6(device: 3026, 1546).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that during an angioplasty procedure for a chronic lesion in the brachiocephalic vein, the physician allegedly had difficulty positioning the balloon for inflation.The pta balloon was inflated 6 to 8 atm with a 20 ml syringe; although blood return was identified during the first inflation.Guided fluoroscopy demonstrated the proximal end of the balloon became detached from the catheter.The physician stated that after several unsuccessful attempts made to deflate the balloon, guided fluoroscopy demonstrated complete balloon detachment without migration from the system.The patient was transferred to another hospital for the removal of the pta balloon.The interventional radiologist was able to snare the balloon via femoral vein access and advanced it to the access sheath; however, the balloon could not be deflated or removed over the wire.The patient was taken to surgery for a cut down procedure for successful removal of the pta balloon.The patient was reported to be hemodynamically stable at the conclusion of the procedure.New information: it was reported through the litigation process that during an angioplasty of av fistula, the pta balloon allegedly ruptured, detached, and became dislodged in the patient.The current status of the patient is unknown.

• Brand Name: ATLAS GOLD PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7844661
• MDR Text Key: 119152309
• Report Number: 2020394-2018-01643
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060816
• UDI-Public: (01)00801741060816
• Combination Product (y/n): N
• PMA/PMN Number: K181323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATG80164
• Device Catalogue Number: ATG80164
• Device Lot Number: 93RC0184
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BACLOFEN, LEVOTHYROXINE SODIUM, CARVEDILOL; CLONIDINE, FLOMAX, FOLIC ACID, FUROSEMIDE; GABAPENTIN, HUMALOG, HYDRALAZINE, TIROSINT; NIFEDIPINE, NORCO, PRAVASTATIN; RENAPLEX, TOUJEO SOLOSTAR
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 95