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

Model Number	V1850150
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284); Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.A photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 04/2024).Device pending return.
Event or Problem Description
It was reported that during the preparation of an angioplasty procedure, half broken guidewire was allegedly observed on the balloon tip.The procedure was completed using another device.There was no patient contact.
Event or Problem Description
It was reported that during the preparation of an angioplasty procedure, half broken guidewire was allegedly observed on the balloon tip.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one vascutrak device was returned for evaluation.A segment of a mandrel was noted to be in the returned device.One electronic photo was also provided and show the distal end of a vascutrak.A portion of a mandrel appears to be visible in the balloon, entering through the tip and exiting from the distal rapid exchange port.An evaluation was performed at the manufacturing facility and it was determined the mandrel was likely inadvertently left in the manufactured part.Therefore, the investigation is unconfirmed for the reported broken guidewire, but confirmed for the identified mandrel left in the manufactured device.Based on the evaluation from the manufacturing site, it was determined that an operator error was the most likely cause of the failure.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: 04/2024),.

• Brand Name: VASCUTRAK
• Common Device Name: 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: 16002907
• Report Number: 2020394-2022-00998
• Device Sequence Number: 12406596
• Product Code: PNO
• UDI-Device Identifier: 00801741061691
• UDI-Public: (01)00801741061691
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103459
• 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
• Report Date (Section B): 03/03/2023

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
• Operator of Device: Health Professional
• Device Model Number: V1850150
• Device Catalogue Number: V1850150
• Device Lot Number: GFFR0628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2022
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2021
• 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 Age: 82 YR
• Patient Sex: Male