MAUDE Adverse Event Report: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE

Model Number	GWC-12325LG-FLP
Medical Device Problem Codes	Entrapment of Device (1212); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The guide wire was received at csi for analysis.Visual examination revealed fibrous material, located at the proximal solder bond.It is hypothesized that the material accumulated on the guide wire after the procedure, and was not considered a contributing factor in the reported event.The guide wire met the drawing specifications, and did not exhibit any damage that would have prevented the guide wire from passing through an exchange catheter.At the conclusion of the device analysis, the reported event could not be confirmed.The material inspection report for this guide wire lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Csi id# (b)(4).
Event or Problem Description
During attempted exchange following atherectomy, the viperwire could not be removed through an exchange catheter due to damage on the spring tip.Multiple catheters were placed to attempt to remove the wire, but it could not be removed via this method.A second wire was inserted to keep placement, and the viperwire wire was removed.The procedure was completed with planned stent placement.The patient was stable.The physician's opinion was that the viperwire may have come into contact with the edge of a stent catheter during use, and the spring tip of the wire may have become misshapen at that time.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• MDR Report Key: 9932702
• Report Number: 3004742232-2020-00106
• Device Sequence Number: 678608
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)210531(10)1113567
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• 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
• Report Date (Section B): 04/07/2020

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 Expiration Date: 05/31/2021
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 11135467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 04/07/2020
• 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
• Patient Age: 64 YR
• Patient Weight: 96