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

Model Number	U35130530
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	01/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number for the device was not provided; therefore, a review of the device history records could not be performed.The return of the device is pending.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that at the completion of an angioplasty procedure in the superficial femoral artery, resistance was allegedly felt when removing the guidewire.The pta balloon and guidewire were removed as a single unit, which resulted in a tear at the access site the left common femoral artery.It was further reported that there was bleeding at the access site, for about an hour.The bleeding was stopped with astriction and no further treatment was needed.There were no further complications to the patient.
Event or Problem Description
It was reported that at the completion of an angioplasty procedure in the superficial femoral artery, resistance was allegedly felt when removing the guidewire.The pta balloon and guidewire were removed as a single unit, which resulted in a tear at the access site the left common femoral artery.It was further reported that there was bleeding at the access site, for about an hour.The bleeding was stopped with astriction and no further treatment was needed.There were no further complications to the patient.
Additional Manufacturer Narrative
The lot number for the device was not provided; therefore, a review of the device history records could not be performed.The device has been returned for evaluation.The investigation of the reported event is currently underway.
Additional Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be conducted, as the lot number was not reported for this device.Investigation summary: the device was returned for evaluation.No visual anomalies were noted with the returned device.An in-house 0.035" guidewire was able to pass without issue through the returned catheter.Therefore, the investigation is unconfirmed for the alleged guidewire issues.The definitive root cause for the reported rupture could not be determined based upon the available information.Label 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 at the completion of an angioplasty procedure in the superficial femoral artery, resistance was allegedly felt when removing the guidewire.The pta balloon and guidewire were removed as a single unit, which resulted in a tear at the access site the left common femoral artery.It was further reported that there was bleeding at the access site, for about an hour.The bleeding was stopped with astriction and no further treatment was needed.There were no further complications to the patient.

• 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: 8351115
• Report Number: 2020394-2019-00137
• Device Sequence Number: 2254011
• Product Code: LIT
• UDI-Device Identifier: 00801741092756
• UDI-Public: (01)00801741092756
• 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,Followup
• Report Date (Section B): 07/25/2019

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: U35130530
• Device Catalogue Number: U35130530
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 04/02/2019; 07/02/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 04/19/2019; 07/25/2019
• 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: Other; Required Intervention