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

Model Number ATG120264

Device Problems Material Frayed (1262); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 05/2023).

Event Description

It was reported that during an angioplasty procedure in the heart valve, the pta balloon allegedly detached from catheter shaft.It was further reported that the detached segment was recovered.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one atlas gold pta dilatation catheter in two segments has returned for evaluation.On the visual evaluation the sample appeared bloody.The first segments contain the detached balloon, and the distal end has prolapsed.Additionally, frayed balloon material was noted.The segment two consist of exposed inner guidewire lumen with marker bands present and the remaining catheter.The catheter appeared stretched.Each segment was observed under the microscope.No other anomalies noted.No functional evaluation performed due to the condition of the device.Therefore, the reported detachment of device is confirmed for, as the device was returned as two separates segments.The identified frayed material is also confirmed for, as the balloon was noted to have frayed fibers during evaluation.A definitive root cause for the reported detachment of device and identified frayed material could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Indication of use: used for percutaneous transluminal angioplasty of the peripheral vasculature, including the iliac arteries and iliac and femoral veins, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.This device is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature.This catheter is not for use in coronary arteries.H10: d4 (expiry date: 05/2023), g3 h11: h6 (method, result, conclusion).H11: section a through f - the information provided by bd 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 bd.H3 other text : see h10.

Event Description

It was reported that during an angioplasty procedure in the heart valve, the pta balloon allegedly detached from catheter shaft.It was further reported that the detached segment was recovered.There was no reported patient injury.

• Brand Name: ATLAS GOLD PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11193351
• MDR Text Key: 227543535
• Report Number: 2020394-2020-21080
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741061066
• UDI-Public: (01)00801741061066
• Combination Product (y/n): N
• PMA/PMN Number: K181323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

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 Model Number: ATG120264
• Device Catalogue Number: ATG120264
• Device Lot Number: 93SE0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 05/11/2021
• Supplement Dates FDA Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other