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

Model Number	ATG80166
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/23/2020
Type of Reportable Event	Serious Injury
Additional 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.Expiry date (11/2022).
Event or Problem Description
It was reported that during an angioplasty procedure in the common femoral and iliac vein, the pta balloon allegedly detached from the catheter shaft.It was further reported that the detached segment was lodged into the subcutaneous tissue.Reportedly, the patient required medical intervention to cutdown and remove the detached segment.The patient was discharged from the hospital the next day post procedure.
Event or Problem Description
It was reported that during an angioplasty procedure in the common femoral and iliac vein, the pta balloon allegedly detached from the catheter shaft and had a retraction issue.It was further reported that the detached segment was lodged into the subcutaneous tissue.Reportedly, the patient required medical intervention to cutdown and remove the detached segment.The patient was discharged from the hospital the next day post procedure.
Additional Manufacturer Narrative
Manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: the investigation is inconclusive for the reported failure balloon detachment and retraction problem, as the device was not returned for evaluation.The definitive root cause for the reported failure balloon detachment and retraction problem 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.Expiry date (11/2022).

• Brand Name: ATLAS GOLD PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10117900
• Report Number: 2020394-2020-03620
• Device Sequence Number: 2309778
• Product Code: LIT
• UDI-Device Identifier: 00801741060830
• UDI-Public: (01)00801741060830
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ATG80166
• Device Catalogue Number: ATG80166
• Device Lot Number: 93XD0173
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention