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

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

The lot number for the device was not provided; therefore, a review of the device history records could not be performed.The return of the device is pending.The investigation of the reported event is currently underway.

Event Description

It was reported that during an angioplasty procedure in the subclavian artery, the pta balloon had detached material.The patient was taken to the emergency room for removal of detached material, via the femoral artery.There were no further complications to the patient.

Manufacturer Narrative

The lot number for the device was not provided; therefore, a review of the device history records could not be 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 artery, the pta balloon had detached material.The patient was taken to the emergency room for removal of detached material, via the femoral artery.There were no further complications to the patient.

Manufacturer Narrative

This supplemental emdr was submitted to report the product information, catalog no.Atg80164, received on 3/5/2019.The lot number for the device was not provided; therefore, a review of the device history records could not be 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 artery, the pta balloon had detached material.The patient was taken to the emergency room for removal of detached material, via the femoral artery.There were no further complications to the patient.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be conducted, as the lot number is unknown for this device.Investigation summary: the device was returned for evaluation.A visual inspection found the device returned with the balloon fully detached at both the distal and proximal weld locations.The balloon was not returned.Therefore, the investigation is confirmed for balloon detachment.Additionally, the inner lumen was noted to be stretched.Based on the detachment balloon and stretched inner lumen, the investigation is confirmed for retraction issues.The distal marker band was returned dislodged on the inner lumen so the investigation is confirmed for dislodgement.The marker band likely dislodged as the inner lumen stretched and as the balloon detached distally.It is likely that the balloon detachment resulted in the retraction issues through the sheath.However, the definitive root cause for the identified balloon detachment could not be determined based on 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.

Event Description

It was reported that during an angioplasty procedure in the subclavian artery, the pta balloon had detached material.The patient was taken to the emergency room for removal of detached material, via the femoral artery.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: 8343806
• MDR Text Key: 136276365
• Report Number: 2020394-2019-00132
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATG80144
• Device Catalogue Number: ATG80164
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Date Manufacturer Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR