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

Model Number	ATG80184
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/23/2019
Type of Reportable Event	Serious Injury
Additional 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.(expiry date: 01/2022).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly difficult to retract.It was further reported that the pta balloon detached during retraction.A secondary procedure was done to remove the detached balloon.The procedure was completed using a new balloon.There were no further reported complications.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation results: the device was returned for evaluation.A visual inspection found that the balloon was detached from the catheter shaft of the device.The balloon was not returned for evaluation.Therefore, the investigation is confirmed for the reported balloon detachment and confirmed for the reported retraction issue.It is likely that the alleged retraction issue contributed to the reported balloon detachment.However, the definite root cause for the reported retraction issue 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.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly difficult to retract.It was further reported that the pta balloon detached during retraction.A secondary procedure was done to remove the detached balloon.The procedure was completed using a new balloon.There were no further reported complications.

• 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: 8680979
• Report Number: 2020394-2019-00902
• Device Sequence Number: 11280963
• Product Code: LIT
• UDI-Device Identifier: 00801741060878
• UDI-Public: (01)00801741060878
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: ATG80184
• Device Catalogue Number: ATG80184
• Device Lot Number: 93ND0080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 11/05/2019
• 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
• Patient Age: 53 YR