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

Model Number	U357554
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard represents all of 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 bard.
Event or Problem Description
It was reported that during an angioplasty procedure of a left upper arm brachiocephalic fistula, the pta balloon allegedly ruptured at 17atm.It was further reported that the balloon partially detached from the catheter shaft.There was difficulty retracting the balloon through the sheath.The balloon and sheath were removed together as one unit over the guidewire.Another balloon was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure of a left upper arm brachiocephalic fistula, the pta balloon allegedly ruptured at 17atm.It was further reported that the balloon partially detached from the catheter shaft.There was difficulty retracting the balloon through the sheath.The balloon and sheath were removed together as one unit over the guidewire.Another balloon was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
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.The device was returned for evaluation.A visual inspection found a complete circumferential rupture in the balloon and a complete detachment of the inner lumen.The detached portion of the balloon, inner lumen, and distal tip was not returned.Therefore, the investigation is confirmed for a circumferential rupture and for balloon and catheter detachments.Additionally, the distal marker band was noted to be dislodged on the inner lumen.Therefore the investigation is conformed for dislodgment.The investigation is inconclusive for the reported retraction issues, as the sheath and detached segment was not returned.It is likely that the balloon rupture led to difficulties pulling the device through the introducer sheath, and subsequent detachments.However, the definitive root cause for the balloon rupture or other identified issues rupture could not be determined based upon available information.It is possible that the original sheath used contributed to the reported issue.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(b)(4).

• 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: 7785842
• Report Number: 2020394-2018-01467
• Device Sequence Number: 1719960
• Product Code: LIT
• UDI-Device Identifier: 00801741092459
• UDI-Public: (01)00801741092459
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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 Expiration Date: 12/31/2020
• Device Model Number: U357554
• Device Catalogue Number: U357554
• Device Lot Number: CMCN0181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 65