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

Model Number	U3575630
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no 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 return of the device is pending.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 treatment of the sfa below the knee with a pta balloon dilation catheter, when attempting to remove the sheath after deflation, the balloon catheter allegedly got stuck in the sheath.Further, the balloon, guidewire, and sheath were removed as a single unit.Reportedly, the health care provider use another balloon catheter 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.One ultraverse 035 catheter was returned inside a cordis 5fr sheath.The visually inspected and found to be stuck inside the sheath with evidence of balloon bunching and sheath buckling at the distal end.Functional testing was unable to be performed.However, the investigation is confirmed for retraction issues at the balloon was bunched, which is an indication of the issue.Per the reported event a 014" guidewire was used with the pta catheter.Ifu states the compatible guidewire for this catheter would be an 035".It is unknown if this use error contributed to the retraction issue.However, the definitive root cause for the balloon becoming stuck in the sheath could not be determined based upon available information.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 treatment of the sfa below the knee with a pta balloon dilation catheter, when attempting to remove the sheath after deflation, the balloon catheter allegedly got stuck in the sheath.Further, the balloon, guidewire, and sheath were removed as a single unit.Reportedly, the health care provider use another balloon catheter to complete the procedure.There was no reported patient injury.

• Brand Name: ULTRAVERSE PTA BALLOON 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: 7455940
• Report Number: 2020394-2018-00461
• Device Sequence Number: 13796192
• Product Code: LIT
• UDI-Device Identifier: 00801741093036
• UDI-Public: (01)00801741093036
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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: 05/31/2020
• Device Model Number: U3575630
• Device Catalogue Number: U3575630
• Device Lot Number: CMBT0461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 62