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

Catalog Number ATG80164

Device Problems Break (1069); Material Frayed (1262); Peeled/Delaminated (1454); Retraction Problem (1536); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(b)(4).

Event Description

It was reported that during an angioplasty procedure in the left subclavian vein, the pta balloon material allegedly detached from the catheter shaft during retraction through the sheath.Reportedly, the balloon material did remain attached to the catheter shaft.The balloon was removed in its entirety through the sheath without difficulty.The procedure was completed with another balloon.There was no reported patient injury.

Manufacturer Narrative

The device history records have been reviewed and 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.The device was returned inserted through the user's introducer sheath for evaluation.A visual inspection device found a complete break to the proximal weld joint of the balloon.Additionally, the catheter inner lumen was stretched and the sheath tip was noted to be flared.Therefore, the investigation is confirmed for a complete break of the proximal balloon joint, as well as for sheath-related retraction issues.It is likely that the user perceived the weld break as a detachment.The definitive root cause for the identified weld break or retraction issue could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

Event Description

It was reported that during an angioplasty procedure in the left subclavian vein, the pta balloon material allegedly detached from the catheter shaft during retraction through the sheath.Reportedly, the balloon material did remain attached to the catheter shaft.The balloon was removed in its entirety through the sheath without difficulty.The procedure was completed with another balloon.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
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens TX 75751
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7612339
• MDR Text Key: 111448423
• Report Number: 2020394-2018-00910
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060816
• UDI-Public: (01)00801741060816
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

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: 04/05/2021
• Device Catalogue Number: ATG80164
• Device Lot Number: 93QC0160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 08/15/2018
• Supplement Dates FDA Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2018
• 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: 85