MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER; PTA DILATATION BALLOON CATHETER

Catalog Number U35130512

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2016

Event Type  malfunction  

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 inspection: the balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 5mm x 120mm balloon.The balloon was returned in its original folded configuration.The catheter was kinked 8.3cm, 11.4cm, and 13.4cm from the distal tip.However after review of the preliminary pictures, the manner in which the device was packaged for return may have contributed to the kinks.No kinks were reported by the user.No anomalies were noted to the strain relief or the y-hub.Functional/performance evaluation: the patency was tested using an in-house.035¿ guide wire and the guide wire was unable to be advanced past the kinks in the catheter.The strain relief was removed and a partial circumferential catheter shaft break was observed at the distal end of the y-hub.Sanding marks were noted on the catheter underneath the strain relief and at the location of 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 device was returned.The investigation is confirmed for a partial circumferential catheter shaft break just distal to the y-hub.The investigation is inconclusive for failure to advance, as functional testing could not be performed due to the poor sample condition (i.E.Kinked catheter).Excessive sanding of the catheter under the strain relief is the root cause for the partial break in the catheter.Per the reported event details, the tracking path was mildly calcified.Therefore, it is possible that patient factors contributed to the failure to advance through the lesion.Labeling review: the current ultraverse 035 pta balloon 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 that the pta balloon allegedly would not cross the lesion over the guidewire in the right sfa.It was further reported that there was alleged mild calcification in the tracking path; however, there was no reported difficulty in retracting the balloon through the sheath.Another balloon was reported to be used to complete the procedure.There was no reported patient injury.

• Brand Name: ULTRAVERSE 035 PTA 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): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5764067
• MDR Text Key: 48621027
• Report Number: 2020394-2016-00599
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142261
• 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
• Report Date: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: U35130512
• Device Lot Number: 50112648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2014
• 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