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

Model Number AT75126

Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, videos were provided for review.The investigation of the reported event is currently underway.(expiration date: 05/2024).

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to inflate.It was further reported that the distal end of the balloon was failed to expand.Reportedly user tried to flat the balloon, but the balloon was unable to be deflated.The balloon was removed from patient.There was no reported patient injury.

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: one atlas pta dilatation catheter has returned for evaluation.No specific anomalies noted during the visual evaluation.On the functional evaluation, the returned device was attempted to inflate with the in-house presto inflation device, but it was unsuccessful and not able to maintain the pressure.The catheter shaft was cut multiple times and connected with the touhy adapter to inflate but it was unable to inflate.The balloon was cut and under the magnification it was noted the glue bullet was positioned within the catheter.No further testing was performed.One radiographic video was reviewed.A video shows a procedure taking place with an interventionalist holding an insufflation device for an angioplasty balloon.The device shows the pressure at ~ 18 atm.The video then pans to the fluoroscopy screen, and wires and catheters appear in the right chest and running next to the heart and down towards the abdomen.An angioplasty balloon is not seen inflated.Therefore, based on the video review, the reported material deformation, inflation and deflation issue could not be confirmed on the findings no conclusion can be made.One video was reviewed.The video shows the balloon was noted to fully inflated and connected with an unknown inflation device, however the pressure gauge needle was noted to be at 0 atm, no other specific anomalies noted.Therefore, based on the video review, the reported deflation issue can be confirmed as the balloon couldn't be deflated although the inflation device depressurize to 0 atm and balloon remains in inflated condition.However, based on the video review the reported material deformation and inflation issue remains inconclusive and no conclusion can be made.Therefore, the investigation for the reported material deformation and inflation issue was confirmed as the returned balloon was unable to inflate during the functional evaluation of the returned device.The investigation was also confirmed for the reported deflation issue as the balloon unable to deflate although the pressure dropped to 0 atm which was observed from the submitted video.During the microscopic observation it was noted the glue bullet was positioned within the catheter might cause to the reported inflation, deflation issues.However, the definitive root cause for the reported material deformation, inflation issue and deflation issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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.H3 other text : see h10.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to inflate.It was further reported that the distal end of the balloon was failed to expand.Reportedly user tried to flat the balloon, but the balloon was unable to be deflated.The balloon was removed from patient.There was no reported patient injury.

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: one atlas pta dilatation catheter has been returned for evaluation.No specific anomalies noted during the visual evaluation.On the functional evaluation, the returned device was attempted to inflate with the in-house presto inflation device, but it was unsuccessful and not able to maintain the pressure.The catheter shaft was cut multiple times and connected with the touhy adapter to inflate but it was unable to inflate.The balloon was cut and under the magnification it was noted the glue bullet was positioned within the catheter.No further testing was performed.One radiographic video was reviewed.A video shows a procedure taking place with an interventionalist holding an insufflation device for an angioplasty balloon.The device shows the pressure at ~ 18 atm.The video then pans to the fluoroscopy screen, and wires and catheters appear in the right chest and running next to the heart and down towards the abdomen.An angioplasty balloon is not seen inflated.Therefore, based on the video review, the reported material deformation, inflation, deflation issue and difficult to remove could not be confirmed on the findings no conclusion can be made.One video was reviewed.The video shows the balloon was noted to be fully inflated and connected with a unknown inflation device, however the pressure gauge needle was noted to be at 0 atm, no other specific anomalies noted.Therefore, based on the video review, the reported deflation issue can be confirmed as the balloon couldn't be deflated although the inflation device depressurize to 0 atm and balloon remains in inflated condition.However, based on the video review the reported material deformation, inflation issue and difficult to remove remains inconclusive and no conclusion can be made.Therefore, the investigation for the reported material deformation and inflation issue was confirmed as the returned balloon was unable to inflate during the functional evaluation of the returned device.The investigation was also confirmed for the reported deflation issue as the balloon was unable to deflate although the pressure dropped to 0 atm which was observed from the submitted video.The investigation for the reported difficult to remove remains inconclusive as no further testing couldn¿t be able to perform due to the condition of the device.During the microscopic observation it was noted the glue bullet was positioned within the catheter might cause to the reported inflation, deflation issues.However, the definitive root cause for the reported material deformation, inflation issue, deflation issue and difficult to remove could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 05/2024), g3, h6 (device).H11: b5.H11: section a through f ¿ the information provide by bd represents all 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.H3 other text : see h10.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly got expanded only in the proximal end but failed to expand in the distal end of the balloon.It was further reported that the balloon was unable to be deflated and had retraction issues.The balloon was removed from patient.There was no reported patient injury.

• Brand Name: ATLAS
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13340806
• MDR Text Key: 284462815
• Report Number: 2020394-2021-02197
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062414
• UDI-Public: (01)00801741062414
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AT75126
• Device Catalogue Number: AT75126
• Device Lot Number: GFFS2599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2021
• Initial Date FDA Received: 01/25/2022
• Supplement Dates Manufacturer Received: 02/01/2022; 03/10/2022
• Supplement Dates FDA Received: 02/04/2022; 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male