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

Model Number	AT75146
Medical Device Problem Codes	Material Frayed (1262); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date 07/2021).
Event or Problem Description
It was reported that during an angioplasty procedure of the svc, the guidewire allegedly failed to load through the pta balloon catheter.Another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.A visual inspection found slight fiber fraying throughout the length of the balloon.Therefore, the investigation is confirmed for frayed fibers.Kinks were noted in the catheter shaft.A guidewire patency test was completed, and difficulty inserting the guidewire past the kinks was noted.Therefore, the investigation is confirmed for the reported guidewire issue and for kinks in the catheter shaft.The kinks in the catheter caused the resistance of the guidewire through the device.However, definitive root cause for the identified kinks or frayed fibers could not be determined based upon 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 angioplasty procedure of the svc, the guidewire allegedly failed to load through the pta balloon catheter.Another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: ATLAS PTA DILATATION CATHETER
• Common Device Name: PTA DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8118552
• Report Number: 2020394-2018-02138
• Device Sequence Number: 1682597
• Product Code: DQY
• UDI-Device Identifier: 00801741062445
• UDI-Public: (01)00801741062445
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K120971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2019

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: AT75146
• Device Catalogue Number: AT75146
• Device Lot Number: GFCU3634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR