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

Model Number ATG80164

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

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

Event Date 02/04/2019

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 is currently under way.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 the first inflation of the pta balloon catheter in the right innominate vein, the balloon allegedly ruptured (atm unknown) and detached from the catheter.It was further reported that multiple attempts to snare the detached balloon fragment with a snare device were made but were unsuccessful.The patient was transferred to the er for surgical removal of the detached balloon fragment.Patient status was stable post surgery.

Event Description

It was reported that during the first inflation of the pta balloon catheter in the right innominate vein, the balloon allegedly ruptured (atm unknown) and detached from the catheter.It was further reported that multiple attempts to snare the detached balloon fragment with a snare device were made but were unsuccessful.The patient was transferred to the er for surgical removal of the detached balloon fragment.Patient status was stable post surgery.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be conducted, as the lot number was not reported for this device.Investigation summary: the investigation is inconclusive for the reported balloon rupture and detachment, as the device was not returned for evaluation.The definitive root cause for the reported rupture or 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.

• 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: 8446336
• MDR Text Key: 139671071
• Report Number: 2020394-2019-00198
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060816
• UDI-Public: (01)00801741060816
• Combination Product (y/n): N
• PMA/PMN Number: K122984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATG80164
• Device Catalogue Number: ATG80164
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 91