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

Model Number	U35130630
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2018
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.Expiry date (01/2019).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 in the sfa using an antegrade approach, the pta balloon allegedly got stuck inside the 6fr sheath and subsequently could not be retracted.The balloon and sheath were removed as one unit.The procedure was concluded, and no further treatment was provided.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.A visual inspection found the device stuck in the user's introducer sheath.The balloon was protruding from the sheath tip, and the tip of the sheath was flared.Stretching was noted through the length of the device.Therefore, the investigation is confirmed for sheath-related retraction issues.Additionally, a complete circumferential rupture was identified in the barrel of a balloon.It is possible that the balloon rupture lead to the retraction issue.However, the definitive root cause for the balloon rupture or retraction issue could not be determined based upon the 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.Expiry date (01/2019).
Event or Problem Description
It was reported that during an angioplasty procedure in the sfa using an antegrade approach, the pta balloon allegedly got stuck inside the 6fr sheath and subsequently could not be retracted.The balloon and sheath were removed as one unit.The procedure was concluded, and no further treatment was provided.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: 7617463
• Report Number: 2020394-2018-00917
• Device Sequence Number: 11118289
• Product Code: LIT
• UDI-Device Identifier: 00801741093258
• UDI-Public: (01)00801741093258
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2018

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 Model Number: U35130630
• Device Catalogue Number: U35130630
• Device Lot Number: 50134507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1