MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U3575610
Medical Device Problem Codes	Deflation Problem (1149); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)
Date of Event	11/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 01/2021).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly had issues deflating.There was no reported patient injury.
Additional Manufacturer Narrative
This supplemental emdr was sent to reflect the changes in the file, due to information received on 1/3/2019.Field b1, adverse event report type, was changed after receipt of new information, thus requiring a supplemental emdr within 30 days.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 01/2021).
Event or Problem Description
It was reported that during an angioplasty procedure in the left superficial femoral artery, the pta balloon allegedly had issues deflating.A needle stick was used to puncture and deflation the device.Another device was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure in the left superficial femoral artery, the pta balloon allegedly had issues deflating.A needle stick was used to puncture and deflation the device.Another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.During the visual inspection it was noted that the device was returned in two segments, and the balloon had a tear along its entire length.This damage will be considered incidental as they were not reported and would not have been present at the time of the procedure.Due to the condition of the sample the investigation is inconclusive for the reported deflation issue, as the device was unable to be functionally tested.Based on the evaluation results, the device was unable to be fully functionally tested due to the condition of the sample.Therefore, the definitive root cause for the reported deflation issues could not be determined.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

• Brand Name: ULTRAVERSE 035 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: 8162737
• Report Number: 2020394-2018-02204
• Device Sequence Number: 2120082
• Product Code: LIT
• UDI-Device Identifier: 00801741092985
• UDI-Public: (01)00801741092985
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: U3575610
• Device Catalogue Number: U3575610
• Device Lot Number: CMCP0315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 01/03/2019; 03/27/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 01/31/2019; 04/08/2019
• 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: Required Intervention