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

Model Number	V184040
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 08/2022).
Event or Problem Description
It was reported that during an angioplasty procedure of calcified target lesion in the superficial femoral artery via ipsilateral approach, the pta balloon allegedly ruptured at 6atm.It was further reported that another device was used to complete the procedure.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 vascutrak catheter was returned for the evaluation.Visual evaluation was performed and noted that device appeared to be bloody.During the functional test, an in-house presto inflation device was used to inflate the balloon and it was noticed that water was exiting near the distal end of the balloon.Then microscopic evaluation was performed and pinhole rupture was noted near to distal tip portion of the balloon.Therefore, the investigation is confirmed for the reported balloon rupture , as pinhole balloon rupture was noted during the microscopic evaluation.Per the reported event details, the target lesion was calcified.Therefore, it is possible the interaction between the lesion and the balloon contributed to the reported balloon rupture.However, the definitive root cause for the reported balloon rupture could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.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 or Problem Description
It was reported that during an angioplasty procedure of calcified target lesion in the superficial femoral artery via ipsilateral approach, the pta balloon allegedly ruptured at 6atm.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: VASCUTRAK PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10873407
• Report Number: 2020394-2020-20510
• Device Sequence Number: 17094605
• Product Code: PNO
• UDI-Device Identifier: 00801741061530
• UDI-Public: (01)00801741061530
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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 Model Number: V184040
• Device Catalogue Number: V184040
• Device Lot Number: GFDU3978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: 10/24/2020
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other