MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION CATHETER; BALLOON VALVULOPLASTY CATHETER

Catalog Number	0224512
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2018
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 device was returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during an aortic valvuloplasty procedure, the balloon valvuloplasty catheter allegedly got caught on the guidewire during removal from the patient.The balloon and guidewire were removed together as one unit.It was further reported that after the procedure, significant resistance was felt in order to remove the balloon from the guidewire.There was no reported patient injury.
Additional Manufacturer Narrative
The device history records have been 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.This is the only complaint reported to date for this lot number and failure mode.The device was returned for evaluation.The user's guidewire was also returned for evaluation.A visual inspection found the bunching to the inner lumen of the catheter in the hub.The atraumatic tip of the guidewire was found to be detached from the guidewire and upon further inspection of the catheter, the detached segment was found lodged in the inner guidewire lumen.Therefore, based on the bunching to the inner lumen and the detached segment of the guidewire, the investigation is confirmed for the reported device getting stuck on the guidewire.The user's guidewire was measured to be a 0.030" guidewire as opposed to the recommended 0.035" guidewire.It is possible that this smaller diameter allowed the atraumatic tip to become stuck in the guidewire as the balloon was being tracked over the wire.Although the definitive root cause for the identified guidewire issue could not be determined based on the available information, the user's guidewire likely contributed to the identified issue.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 an aortic valvuloplasty procedure, the balloon valvuloplasty catheter allegedly got caught on the guidewire during removal from the patient.The balloon and guidewire were removed together as one unit.It was further reported that after the procedure, significant resistance was felt in order to remove the balloon from the guidewire.There was no reported patient injury.

• Brand Name: TRUE DILATATION CATHETER
• Common Device Name: BALLOON VALVULOPLASTY CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8118516
• Report Number: 2020394-2018-02139
• Device Sequence Number: 211563
• Product Code: OZT
• UDI-Device Identifier: 00801741091001
• UDI-Public: (01)00801741091001
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K150667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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: 07/08/2020
• Device Catalogue Number: 0224512
• Device Lot Number: GFBU3773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 73