MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. 7 FR VIDA PTV CATHETER; BALLOON VALVULOPLASTY CATHETER

Catalog Number VDA100144

Device Problems Peeled/Delaminated (1454); Retraction Problem (1536); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2015

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device has been provided.A review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation 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 balloon valvuloplasty catheter was allegedly difficult to retract through the sheath after use in the svc.It was further reported that upon removal from the sheath the fibers of the balloon were allegedly unraveled.There was no reported patient injury.

Manufacturer Narrative

A manufacturing review was conducted.The lot met all release criteria.Visual/microscopic inspection: the device was returned used.The balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 14mm x 4cm x 100cm balloon.Loose fibers were noted at the distal cone.Fiber strands were noted to be unraveled at this location, measuring 45.2cm in length.The outer pebax layer was also peeling off the balloon at this location.The balloon was returned partially inflated.No other anomalies were observed along the length of the device.Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house 0.035¿ guidewire, and it passed without issue.The inflation hub was connected to an inflation device and the partially inflated balloon was able to be deflated without issue.An attempt was made to inflate the balloon.Upon inflation, the balloon inflated asymmetrically and ruptured at 3atm.The balloon rupturing is an incidental finding, as it was not reported by the user and likely ruptured due to the unraveled fibers and peeled pebax.The rupture was located 1.2cm from the distal tip and extended longitudally for 2.3cm.No further functional testing could be performed due to sample condition (i.E.Unraveled fibers and balloon rupture) medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the investigation is confirmed for unraveled fibers and peeled pebax.The investigation is inconclusive for sheath related retraction issues, as functional testing for sheath retraction issues could not be performed due to the poor sample condition (i.E.Unraveled fibers).The balloon was inflated near a stent and there may have been an interaction between the stent and balloon which contributed to the unraveled fibers and peeled pebax.The balloon was also returned partially inflated.Therefore, it is possible that the user did not fully deflate the balloon, resulting in the retraction difficulty through the introducer sheath.The partially inflated balloon was able to be deflated without issue during functional testing.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 vida ptv 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.

• Brand Name: 7 FR VIDA PTV CATHETER
• Type of Device: BALLOON VALVULOPLASTY 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: 5275178
• MDR Text Key: 33369419
• Report Number: 2020394-2015-01978
• Device Sequence Number: 1
• Product Code: OMZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: VDA100144
• Device Lot Number: 93HZ0123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2015
• 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 Age: 70 YR
• Patient Weight: 77