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

Model Number ATG120146

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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.

Event Description

It was reported that during an angioplasty procedure in the pelvic area, the pta balloon allegedly detached during dilatation of a venous stent.It was further reported that multiple attempts were made to recover the detached balloon segment but were unsuccessful.The patient was sent to vascular surgery to surgically remove the detached segment.There was no reported patient injury post surgical extraction of the balloon segment.

Manufacturer Narrative

Manufacturing review: 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.Investigation summary: the device was returned for evaluation.A visual inspection found the balloon to be fully detached from both balloon weld locations.The device was examined under microscopic magnification, and balloon material was present at the weld locations.Therefore, the investigation is confirmed for balloon detachment.Per the reported event details, the patient was treated with a venovo venous stent, and reported the detached balloon after dilating with the device.Therefore, it is possible that an interaction with the stent contributed to the identified detached balloon.The definitive root cause for the identified balloon detachment could not be determined based upon 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.

Event Description

It was reported that during an angioplasty procedure in the pelvic area, the pta balloon allegedly detached during dilatation of a venous stent.It was further reported that multiple attempts were made to recover the detached balloon segment but were unsuccessful.The patient was sent to vascular surgery to surgically remove the detached segment.There was no reported patient injury post surgical extraction of the balloon segment.

Manufacturer Narrative

Manufacturing review: 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.Investigation summary: the device was returned for evaluation.A visual inspection found the balloon to be fully detached from both balloon weld locations.The device was examined under microscopic magnification, and balloon material was present at the weld locations.Therefore, the investigation is confirmed for balloon detachment.Per the reported event details, the patient was treated with a venovo venous stent, and reported the detached balloon after dilating with the device.Therefore, it is possible that an interaction with the stent contributed to the identified detached balloon.The definitive root cause for the identified balloon detachment could not be determined based upon 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.

Event Description

It was reported that during an angioplasty procedure in the pelvic area, the pta balloon allegedly detached during dilatation of a venous stent.It was further reported that multiple attempts were made to recover the detached balloon segment but were unsuccessful.The patient was sent to vascular surgery to surgically remove the detached segment.There was no reported patient injury post surgical extraction of the balloon segment.

• 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: 8437627
• MDR Text Key: 139362425
• Report Number: 2020394-2019-00190
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060786
• UDI-Public: (01)00801741060786
• 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,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATG120146
• Device Catalogue Number: ATG120146
• Device Lot Number: 93XC0056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Date Manufacturer Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 15 YR