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

Model Number U41501Q1HRX

Device Problems Peeled/Delaminated (1454); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2016

Event Type  malfunction  

Manufacturer Narrative

As a result of a retrospective review of events that occurred in japan and in accordance with 21 c.F.R.Part 803, this event was assessed and determined to be mdr reportable as a malfunction.No medical records or no medical images have been made available to the manufacturer; however, a photo has been provided.As the lot number for the device was provided, a review of the device history records is currently being 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 during the treatment for chronic total occlusion (cto) with calcification in the left anterior tibial artery (ata) by an ipsilateral antegrade approach, approximately 20 cm of ribbon-like material of the pta catheter was allegedly found when it was removed from the patient.Before the catheter removal, the health care provider attempted to pass the catheter through the lesion but failed.No patient injury was reported.

Manufacturer Narrative

A manufacturing review was performed.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 to date for this lot number and failure mode.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.Image/photo review: one electronic photo was reviewed by field assurance engineer.The photo shows an entire ultraverse rx pta catheter.The catheter has been coiled up.The balloon appears to be deflated, however the distal end of the balloon appears to be bunched.Laying on the paper towels beneath the distal tip of the device, a clear and coiled ribbon-like material was noted.Due to the coiled nature of the material, an approximate length of the material could not be made.Based on the photo review, peeled material can be confirmed.However, advancement issues could not be confirmed.Conclusion: the device was not returned; one photo was returned for review.Based on the photo review peeled material could be confirmed.However, advancement issues could not be identified based on the returned photo.Therefore, the investigation remains inconclusive for advancement issues as the original sample was not returned for evaluation.The definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current ifu (instructions for use) states: warnings: do not exceed the rbp recommended for this device.Balloon rupture may occur if the rbp rating is exceeded.To prevent over pressurization, use of a pressure monitoring device is recommended.Precautions: if resistance is felt during post procedure withdrawal of the catheter through the introducer sheath/guide catheter, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the introducer sheath/guide catheter and then completely evacuate the contrast before proceeding to withdraw the balloon.If resistance is still felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and introducer sheath/guide catheter as a single unit.Use of the ultraverse rx pta dilatation catheter: position the balloon relative to the lesion to be dilated, ensure the guidewire is in place, and inflate the balloon to the appropriate pressure.Potential adverse reactions: additional intervention.

Event Description

It was reported that during the treatment for chronic total occlusion (cto) with calcification in the left anterior tibial artery (ata) by an ipsilateral antegrade approach, approximately 20 cm of ribbon-like material of the pta catheter was allegedly found when it was removed from the patient.Before the catheter removal, the health care provider attempted to pass the catheter through the lesion but failed.No patient injury was reported.

• Brand Name: ULTRAVERSE RX PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION 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: 6556169
• MDR Text Key: 74793747
• Report Number: 2020394-2017-00432
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741055546
• UDI-Public: (01)00801741055546(17)180228(10)50119441
• Combination Product (y/n): N
• PMA/PMN Number: K131199
• 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: 07/13/2017

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 Expiration Date: 02/28/2018
• Device Model Number: U41501Q1HRX
• Device Catalogue Number: U41501Q1HRX
• Device Lot Number: 50119441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2016
• Initial Date FDA Received: 05/09/2017
• Supplement Dates Manufacturer Received: 07/11/2017
• Supplement Dates FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2015
• 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: 73 YR
• Patient Weight: 45