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

Catalog Number V1850300

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 06/10/2016

Event Type  malfunction  

Manufacturer Narrative

No medical records or 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 during an angioplasty procedure in a stenotic sfa with two occlusions, following the second inflation at 15atm of the pta balloon dilatation catheter, the patient allegedly experienced pain at the treatment site.Upon successful removal of the pta balloon, it was reportedly identified that one side of the fixed wire was allegedly detached from the balloon catheter.A drug coated pta balloon dilatation catheter was inserted to complete the procedure with no known injury or damage to the vessel.The vessel was successfully opened and no extravasation was identified.There was no reported consequence or impact to the patient.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.The lot met all release criteria.Visual/microscopic inspection: the balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 5.0mm x 300mm balloon.The distal end of the core wire was observed to be completely separated form the distal tip.The core wire separation was examined under microscopic magnification and the edges of the break at the balloon bond were jagged and stretched, indicating that excessive force contributed to the break.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the investigation is confirmed for a break at the distal balloon/core wire bond, resulting in the distal end of the core wire separating from the distal tip.Per the reported event details, the balloon was inflated to 15atm.The rated burst pressure (rbp) for this balloon size is 12atm; therefore, the balloon was overpressurized.The current ifu (instructions for use) states "do not exceed the rbp recommended for this device.Balloon rupture or difficulty in deflation may occur if the rbp rating is exceeded.To prevent over pressurization, use of a pressure monitoring device is recommended." it is possible that the balloon being inflated past rbp caused added stress to the distal balloon/core wire bond, resulting in the core wire separating from the distal tip.Labeling review: the current vascutrak pta balloon dilatation catheter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.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 during an angioplasty procedure in a stenotic sfa with two occlusions, following the second inflation at 15atm of the pta balloon dilatation catheter, the patient allegedly experienced pain at the treatment site.Upon successful removal of the pta balloon, it was reportedly identified that one side of the fixed wire was allegedly detached from the balloon catheter.A drug coated pta balloon dilatation catheter was inserted to complete the procedure with no known injury or damage to the vessel.The vessel was successfully opened and no extravasation was identified.There was no reported consequence or impact to the patient.

• Brand Name: VASCUTRAK PTA DILATATION BALLOON CATHETER
• Type of Device: PTA DILATATION BALLOON CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5776156
• MDR Text Key: 49033265
• Report Number: 2020394-2016-00617
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K103459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2016
• Device Catalogue Number: V1850300
• Device Lot Number: GFXD2534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2013
• 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