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

Catalog Number 0224512

Device Problems Break (1069); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2018

Event Type  malfunction  

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.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that the valvuloplasty balloon allegedly would not hold the pressure throughout inflation.It was further reported that the balloon was removed from the patient and an attempt to inflate it on the back table allegedly discovered a pin hole rupture at the distal portion of the balloon.Reportedly, the procedure was completed with another valvuloplasty balloon.There was no reported patient injury.

Event Description

It was reported that the valvuloplasty balloon allegedly would not hold the pressure throughout inflation.It was further reported that the balloon was removed from the patient and an attempt to inflate it on the back table allegedly discovered a pin hole rupture at the distal portion of the balloon.Reportedly, the procedure was completed with another valvuloplasty balloon.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: 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.Investigation summary: the device was returned.An inflation test was performed and found to have a partial circumferential break at the distal end of the glue joint.The investigation is confirmed for break as a partial circumferential break was noted.The investigation is unconfirmed for rupture as the failure was actually a break at the glue joint.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.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.(expiration date:09/2020).

• Brand Name: TRUE DILATATION CATHETER
• Type of Device: VALVULOPLASTY BALLOON
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7492609
• MDR Text Key: 107570193
• Report Number: 2020394-2018-00584
• Device Sequence Number: 1
• Product Code: OZT
• UDI-Device Identifier: 00801741091001
• UDI-Public: (01)00801741091001
• Combination Product (y/n): N
• PMA/PMN Number: K150667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0224512
• Device Lot Number: GFBW2953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Date Manufacturer Received: 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR