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

Catalog Number	0214512
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/07/2018
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 return of the device is pending.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 preparation for an aortic valvuloplasty procedure the balloon catheter allegedly was aspirating air.There was no patient contact.
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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.A microscopic inspection of the hub found the presence of air bubbles in the glue between the guidewire lumen and the hub.The bubbles appeared to be connected in a continuous channel.The device was aspirated per the instructions for use, and a stream of the bubbles was noted to be flowing into the system through the air bubbles along the hub.Therefore, the investigation is confirmed for the reported aspiration issue.Although all balloons are 100% tested at manufacturing for inflation, leaks, and visual anomalies at the hub using ultraviolet light, it is unknown how the returned device was able to aspirate air after inspection at manufacturing.Per the manufacturing review for the reported lot number, no changes in the manufacturing process were noted that would have contributed to the reported event.The definitive root cause for the reported aspiration issue could not be determined based upon available information.Labeling 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 during preparation for an aortic valvuloplasty procedure the balloon catheter allegedly was aspirating air.There was no patient contact.

• Brand Name: TRUE DILATATION BALLOON VALVULOPLASTY CATHETER
• Common Device Name: BALLOON VALVULOPLASTY CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8138343
• Report Number: 2020394-2018-02166
• Device Sequence Number: 18886238
• Product Code: OZT
• UDI-Device Identifier: 00801741097447
• UDI-Public: (01)00801741097447
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019

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 Catalogue Number: 0214512
• Device Lot Number: GFBT0320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1