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

Model Number ATG80144

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that during an angioplasty procedure in the subclavian vein, the pta balloon allegedly detached from the catheter.The detached material was removed with the use of a snare, utilizing an additional access site.Another device was used to complete the procedure.There were no further complications to the patient.

Manufacturer Narrative

Manufacturing review: per the complaint history review (chr), there has been one complaint reported for this lot number.Based on the severity level and lot quantity, the number of events is within the acceptable quality levels.Investigation summary: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.The device was returned for evaluation.A visual inspection was performed and an incidental kink was noted on the catheter shaft.The balloon was noted to be detached from the proximal and distal glue weld, and appeared to be partially inverted.Balloon material was noted at both glue welds.The inner device lumen was noted to be slightly stretched, and both marker bands were present of the device.Therefore, the investigation is confirmed for the reported balloon detachment, as the balloon was noted to be detached from the proximal and distal glue weld.The definitive root cause for the balloon detachment could not be determined based upon available information.It is unknown whether patient or procedural issues contributed to the event.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.

Event Description

It was reported that during an angioplasty procedure in the subclavian vein, the pta balloon allegedly detached from the catheter.The detached material was removed with the use of a snare, utilizing an additional access site.Another device was used to complete the procedure.There were no further complications to the patient.

• 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: 8967412
• MDR Text Key: 156730417
• Report Number: 2020394-2019-03144
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060755
• UDI-Public: (01)00801741060755
• 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: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2020
• Device Model Number: ATG80144
• Device Catalogue Number: ATG80144
• Device Lot Number: 93YB0184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention