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

Catalog Number 0284514

Device Problem Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2016

Event Type  malfunction  

Manufacturer Narrative

Photo images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been 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balloon allegedly ruptured during the second inflation in the aortic valve.It was further reported that the device was retracted without incident.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: as medical records were not provided, a review could not be performed.Photo review: four photos were provided and reviewed.All four photos show a longitudinal balloon rupture on the proximal end of a true dilatation catheter.The pleats on the balloon are not properly folded and the inner polyimide is visible due to the balloon rupture.The edges of the rupture are jagged in appearance.Based on the photos provided, the complaint investigation is confirmed for a longitudinal balloon rupture on the proximal end of the balloon.Conclusion: based on the photos provided, the investigation is confirmed for a longitudinal balloon rupture on the proximal end of the balloon.As the user reported the volume of the balloon when it ruptured and not the pressure, it is possible that the user was monitoring the volume instead of the pressure, causing the balloon to inflate past rbp when it ruptured.However, the definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the current ifu (instructions for use) states: indications: the true dilatation balloon valvuloplasty catheter is indicated for balloon aortic valvuloplasty.Warnings & precautions: do not exceed maximum inflation pressure indicated on label.Excess inflation pressure can cause balloon rupture and the inability to withdraw catheter through introducer sheath.Potential complications/adverse events: in the very unlikely event of balloon burst or rupture, balloon could be more difficult to remove through the sheath and could require introducer sheath removal.Potential complications include, but are not limited to: tissue perforation, conduction system injury, thromboembolic events, hematoma, cardiovascular injury, arrhythmia development, annular or valvular tearing or trauma, restenosis development, inflammation, infection.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.

• Brand Name: TRUE DILATATION CATHETER
• Type of Device: DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5570980
• MDR Text Key: 42993838
• Report Number: 2020394-2016-00348
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 0284514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 04/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 79