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

Model Number AT120144

Device Problems Material Frayed (1262); Peeled/Delaminated (1454); Unraveled Material (1664); Failure to Advance (2524); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.(expiration date: 12/2020).

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly could not advance over the wire after being inflated inside a stent.It was further reported that after removing the balloon from the patient, unraveled material was found.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure in the iliac vein, the pta balloon allegedly could not advance over the wire after being inflated inside a stent.It was further reported that after removing the balloon from the patient, unraveled material was found.No further treatment was needed.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This 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.Investigation summary: the device was returned for evaluation.A visual inspection found unraveled and frayed fibers along the length of the device.Additionally, the outer balloon layer was also found to be peeled on the balloon.Therefore, the investigation is confirmed for the reported unraveled fibers and identified frayed fibers and peeled outer layer.Furthermore, the investigation is unconfirmed for the reported advancement issues over the wire as well as for the withdrawal issues from the wire, as an in-house guidewire was inserted through the device without issue.Per the reported event details, the device was inflated inside a stent during the procedure.Therefore, it is possible that the interaction between the stent and the balloon contributed to the identified issues.However, the definitive root cause for the reported and identified issues could not be determined based upon the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiration date: 12/2020).(removed device codes: 2524 - failure to advance, 2919 - device-device incompatibility; added device codes: 1262 - material frayed, 1454 - peeled.

• Brand Name: ATLAS 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: 8015993
• MDR Text Key: 125364464
• Report Number: 2020394-2018-01947
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062636
• UDI-Public: (01)00801741062636
• Combination Product (y/n): N
• PMA/PMN Number: K120971
• 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: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AT120144
• Device Catalogue Number: AT120144
• Device Lot Number: GFBZ1806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Date Manufacturer Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR