MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U4150215
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/30/2018
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.
Event or Problem Description
It was reported that while trying to load the pta balloon over the guidewire the distal tip of the balloon allegedly detached.Another balloon was used to perform the procedure.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The 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 for this lot number and issue to date.Investigation summary: the device was returned for evaluation.A complete detachment of a portion of the distal tip was identified.The detached portion was not returned for evaluation.Therefore, the investigation is confirmed for the reported detached tip.The definitive root cause for the tip detachment could not be determined based on the available information.It is unknown if procedural issues contributed to the reported event.Labeling review: the current ifu (instructions for use) states: dilatation catheter preparation: - remove the balloon guard and stylet by grasping the balloon catheter just proximal to the balloon and with the other hand, gently grasp the balloon protector and slide distally off of the balloon catheter.Precautions: - if resistance is felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit.
Event or Problem Description
It was reported that while trying to load the pta balloon over the guidewire the distal tip of the balloon allegedly detached.Another balloon was used to perform the procedure.There was no patient contact.

• Brand Name: ULTRAVERSE 014 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: 7317646
• Report Number: 2020394-2018-00198
• Device Sequence Number: 10800906
• Product Code: LIT
• UDI-Device Identifier: 00801741053443
• UDI-Public: (01)00801741053443
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

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: 08/31/2020
• Device Model Number: U4150215
• Device Catalogue Number: U4150215
• Device Lot Number: CMBW0533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1