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

Model Number	U357532
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date 05/2019).
Event or Problem Description
It was reported that during a fistulagram, the pta balloon allegedly had a leak at the connection hub.Another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was conducted on the dhr, mrb, receiving inspection, internal rejects history, manufacturing controls and fmeas.The manufacturing review did not indicated any possible manufacturing issue that could be related to the reported event.Investigation summary: the device was receive for evaluation.A visual inspection found deep sanding marks on the catheter shaft, underneath the strain relief.The sanding marks were examined and a partial break was noted in the shaft.An attempt was then made to inflate the device, and water was noted to leak from the break.Therefore, the investigation is confirmed for the reported leak, and for a partial break in the catheter shaft.Per the evaluation, sanding marks were identified distally past the hub (extending past the sanding maximum range); therefore, excessive sanding of the catheter under the strain relief is the root cause for the partial break in the catheter.An event was opened and closed to address this issue.The operator was retrained.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.
Event or Problem Description
It was reported that during a fistulagram, the pta balloon allegedly had a leak at the connection hub.Another device was used to complete the procedure.There was no reported patient injury.

• 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: 8215176
• Report Number: 2020394-2018-02268
• Device Sequence Number: 2025774
• Product Code: LIT
• UDI-Device Identifier: 00801741091445
• UDI-Public: (01)00801741091445
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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: U357532
• Device Catalogue Number: U357532
• Device Lot Number: CMAT0044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR