MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VACCESS PTA BALLOON DILATATION CATHETER

Catalog Number VA8094

Device Problems Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2014

Event Type  malfunction  

Manufacturer Narrative

A further clinical review of the event details was completed and a change in the mdr reportability was identified.No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has 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 pta balloon dilatation catheter luer connection was misshapen.Reportedly, the luer connection was oval instead of round.There was no patient involvement.

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records were reviewed.The 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 for this lot number and issue to date.Visual/microscopic inspection: the sample appeared to be clean.No anomalies or deformations were noted to the distal tip of the balloon.The inflation hub and guidewire hub did not appear to be deformed; however, an unknown plastic material was present inside the guidewire hub.The guidewire hub was examined under magnification (20x) and the unknown plastic material was cyclindrical in shape, with a hole running through its length.The top surface of the plastic material appeared to be rough and jagged, possibly indicating that it had been broken off of an object.Functional/performance evaluation: the patency of the guidewire lumen was tested and it passed without issue.With the guidewire in place, the inflation hub was connected to an inflation device without issue.The guidewire was removed and an attempt was made to connect the inflation device to the guidewire hub.The inflation device was unable to attach to the guidewire hub due to the plastic material inside the hub.Medical records & image/photo review: no medical records or images/photos were provided for review.Conclusion: the investigation is unconfirmed for material deformation, as no material deformation was found to the inflation/guidewire hubs.The investigation is confirmed for foreign material present in the device, as a plastic male portion of a stopcock luer was found broken off inside the guidewire hub.The clear plastic material found inside the guidewire hub is not a part of the hub.The manufacturing process was reviewed by the manufacturer, and it was determined that the clear plastic found inside the guidewire hub was a male portion of a stopcock luer that had broken off inside the hub.During production, the stopcock luer is attached to the leak test fixture to blow out/leak test the guidewire hub and lumen.Although the stopcock luer is made of a tough, versatile plastic, over time it develops stress cracks and has the potential to break.Labeling review: specific warnings, precautions and directions for use of the access pta dilatation catheter are included in the current instructions for use (ifu).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: VACCESS PTA BALLOON DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens TX 75751
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5360011
• MDR Text Key: 35810440
• Report Number: 2020394-2016-00117
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111850
• 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: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: VA8094
• Device Lot Number: 93KX0173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2013
• 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