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

Catalog Number AT75144

Device Problems Material Frayed (1262); Unraveled Material (1664)

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

Event Date 07/05/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2026).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.

Event Description

It was reported that during an angioplasty procedure in the venous fistula, the pta balloon allegedly shredded after balloon was inflated and deflated and was pulled out of the sheath.It was further reported that the balloon was inflated and deflated fine just ¿shredded¿ when removed from the sheath.The procedure was completed using another balloon.There was no reported patient injury.

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: the physical device was not returned for evaluation.One photo was reviewed.The photo shows the balloon catheter out of the patient's body and through the introducer sheath.The balloon was noted to be in a deflated condition.It appeared bloody, unraveled fibers of balloon material were observed near to its distal end.No other anomalies noted.As the submitted photo confirms the unraveled fiber of balloon material, therefore the investigation is confirmed for the reported unraveled fibers.A definitive root cause for the reported unraveled fibers 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: 03/2026), g3, h6 (method).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.

Event Description

It was reported that during an angioplasty procedure in the venous fistula, the pta balloon allegedly shredded when pulled out of the sheath.The procedure was completed using another balloon.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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17698303
• MDR Text Key: 322825937
• Report Number: 2020394-2023-00661
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062438
• UDI-Public: (01)00801741062438
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

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 Catalogue Number: AT75144
• Device Lot Number: GFHQ1516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 10/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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