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

Model Number	U4150230
Medical Device Problem Codes	Deflation Problem (1149); Retraction Problem (1536); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The facility rep stated that the device was available for evaluation.A sample return kit was sent to the facility and is pending return.The results of the anticipated device evaluation will be provided upon completion of the event investigation.
Event or Problem Description
It was reported that during an angioplasty procedure in the right posterior tibial artery, the pta balloon allegedly would not deflate after the first inflation.Reportedly during retraction the balloon allegedly got stuck on the guidewire; therefore, the pta balloon and guidewire were removed through introducer sheath without incident.A new guidewire and another balloon were used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Conclusion: the investigation is inconclusive, as the sample was not returned for evaluation.The definitive root cause for the reported guidewire issue and deflation issue could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the 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: do not remove the guidewire in situ to shoot contrast through the wire lumen or perform a wire exchange.If the wire is removed while the balloon catheter is situated in tortuous anatomy, the risk of kinking the catheter is increased.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.Potential adverse reactions: (b)(4).
Event or Problem Description
It was reported that during an angioplasty procedure in the right posterior tibial artery, the pta balloon allegedly would not deflate after the first inflation.Reportedly during retraction the balloon allegedly got stuck on the guidewire; therefore, the pta balloon and guidewire were removed through introducer sheath without incident.A new guidewire and another balloon were used to complete the procedure.There was no reported patient injury.

• Brand Name: ULTRAVERSE 014 PTA BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6831815
• Report Number: 2020394-2017-01049
• Device Sequence Number: 872816
• Product Code: LIT
• UDI-Device Identifier: 00801741064425
• UDI-Public: (01)00801741064425
• 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): 10/30/2017

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: 03/31/2020
• Device Model Number: U4150230
• Device Catalogue Number: U4150230
• Device Lot Number: CMBR0410
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 10/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 54