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

Catalog Number	ATG120202
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 06/2024).H11: section a through f ¿ the information provided 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.
Event or Problem Description
It was reported that during an angioplasty procedure, upon withdrawal of the balloon catheter, the pta balloon catheter allegedly had resistance when removing out from the short sheath.It was further reported that upon fluoroscopy, the balloon marker was allegedly found inside the sheath and the balloon was suspected to be dislodged as only the marker was seen on the catheter without the balloon.Reportedly, the balloon catheter, the dislodged balloon and the short sheath were removed successfully over the guidewire and the balloon was found to be trapped inside the sheath and remained intact.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, upon withdrawal of the balloon catheter, the pta balloon catheter allegedly had resistance when removing out from the short sheath.It was further reported that upon fluoroscopy, the balloon marker was allegedly found inside the sheath and the balloon was suspected to be dislodged as only the marker was seen on the catheter without the balloon.Reportedly, the balloon catheter, the dislodged balloon and the short sheath were removed successfully over the guidewire and the balloon was found to be trapped inside the sheath and remained intact.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one atlas gold pta catheter was received with an unknown brand sheath over the balloon for evaluation.During visual analysis the distal side of the balloon struck and striked out from the sheath as sheath poked condition and balloon had break from the proximal end of the catheter shaft, exposing the inner guide wire lumen, however the balloon is still intact with the distal end could be observed.Further could noted bunching in the distal end of balloon and the proximal end of balloon break from the catheter shaft.No other anomalies were noted.On functional testing the exertion to pull out the balloon from sheath was failed.Because of the resistance balloon got struck in the sheath could not separated.Due to the condition of device no further functional testing was performed.Hence the visual analysis and functional testing could observed the balloon bunching in distal end, break in proximal end of balloon and removal of balloon from the sheath was failed.Therefore the investigation was confirmed the identified balloon bunching and reported balloon break, balloon removal difficulty from the sheath issues.A definitive root cause for the identified balloon bunching and reported balloon break, balloon removal difficulty from the sheath issue could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 06/2024), g3.H11: section a through f ¿ the information provided 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.
Event or Problem Description
It was reported that during an angioplasty procedure, upon withdrawal of the balloon catheter, the pta balloon catheter allegedly had resistance when removing out from the short sheath.It was further reported that upon fluoroscopy, the balloon marker was allegedly found inside the sheath and the balloon was suspected to be dislodged as only the marker was seen on the catheter without the balloon.Reportedly, the balloon catheter, the dislodged balloon and the short sheath were removed successfully over the guidewire and the balloon was found to be trapped inside the sheath and remained intact.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one atlas gold pta catheter was received with an unknown brand sheath over the balloon for evaluation.During visual analysis the distal side of the balloon struck and striked out from the sheath as sheath poked condition and balloon had break from the proximal end of the catheter shaft, exposing the inner guide wire lumen, however the balloon is still intact with the distal end could be observed.Further could noted bunching in the distal end of balloon and the proximal end of balloon break from the catheter shaft.No other anomalies were noted.On functional testing the exertion to pull out the balloon from sheath was failed.Because of the resistance balloon got struck in the sheath could not separated.Due to the condition of device no further functional testing was performed.Hence the visual analysis and functional testing could observed the balloon bunching in distal end, break in proximal end of balloon and removal of balloon from the sheath was failed.Therefore the investigation was confirmed the identified balloon bunching and reported balloon break, balloon removal difficulty from the sheath issues.A definitive root cause for the identified balloon bunching and reported balloon break, balloon removal difficulty from the sheath issue could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided 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.

• Brand Name: ATLAS GOLD
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18408085
• Report Number: 2020394-2023-01330
• Device Sequence Number: 2932343
• Product Code: DQY
• UDI-Device Identifier: 00801741060922
• UDI-Public: (01)00801741060922(11)220609(17)240610(10)93TG0037
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/10/2024
• Device Catalogue Number: ATG120202
• Device Lot Number: 93TG0037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 03/05/2024; 06/12/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 03/08/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown