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

Model Number	ATG120164
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the device is pending.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during an iliofemoral angioplasty procedure, the pta balloon allegedly ruptured on the initial inflation attempt.There was no reported patient injury.
Additional 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.Investigation summary: the device was returned for evaluation.A visual inspection found a peeled outer layer on the distal cone of the balloon.An inflation attempt was made and a pinhole rupture was noted on the distal cone at the location of the peeling outer layer.Therefore, the investigation is confirmed for a pinhole rupture and peeled outer layer.It is likely that the rupture contributed to the peeling outer layer.However, the definitive root cause for the identified issues 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 or Problem Description
It was reported that during an iliofemoral angioplasty procedure, the pta balloon allegedly ruptured on the initial inflation attempt.There was no reported patient injury.

• 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: 8189383
• Report Number: 2020394-2018-02243
• Device Sequence Number: 1961101
• Product Code: LIT
• UDI-Device Identifier: 00801741060823
• UDI-Public: (01)00801741060823
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ATG120164
• Device Catalogue Number: ATG120164
• Device Lot Number: 93UC0095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1