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

Model Number	U415044RX
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
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: 05/2023).
Event or Problem Description
It was reported that during an angioplasty procedure in the superficial femoral artery via contralateral approach, the catheter shaft of the pta balloon was allegedly kinked.There was no patient injury.
Additional 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 ultraverse rx pta dilatation catheter has returned for evaluation.On the visual evaluation of the returned device, it consists of two segments.The first segment consists of partial catheter and strain relief.The segment consists of remaining catheter and balloon, the balloon appeared bunched.No other anomalies noted.No functional performed due to the condition of the device.Therefore, the investigation for the reported material deformation remains inconclusive as no evidence noted in the device returned.The investigation is confirmed for the detachment of device as the device returned into two segments for evaluation.A definitive root cause for the alleged material deformation and identified detachment of device could not be determined based upon the provided 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.H10: d4 (expiry date: 05/2023).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 in the superficial femoral artery via contralateral approach, the catheter shaft of the pta balloon was allegedly kinked.There was no patient injury.

• Brand Name: ULTRAVERSE RX 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: 11099800
• Report Number: 2020394-2020-21006
• Device Sequence Number: 3781128
• Product Code: LIT
• UDI-Device Identifier: 00801741057465
• UDI-Public: (01)00801741057465
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131199
• 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): 04/02/2021

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: U415044RX
• Device Catalogue Number: U415044RX
• Device Lot Number: CMET0635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 05/28/2021
• 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