MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHOICE PT; WIRE, GUIDE, CATHETER

Model Number	2085
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.During unpacking of a 300 pt es j choice pt guidewire, it was noted that the tip was broken.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned with its original pouch.The unit returned has distal tip damaged, as part of overall visual revision.The device has the distal tip kinked; its polymer tip was in good condition.No more damages were found.The overall length is within specification.The outside diameter of the distal tip, middle of the device, and the proximal section are within specification.
Event or Problem Description
It was reported that tip detachment occurred.During unpacking of a 300 pt es j choice pt guidewire, it was noted that the tip was broken.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• Brand Name: CHOICE PT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8341054
• Report Number: 2134265-2019-01276
• Device Sequence Number: 16678748
• Product Code: DQX
• UDI-Device Identifier: 08714729252498
• UDI-Public: 08714729252498
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

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 Expiration Date: 05/23/2020
• Device Model Number: 2085
• Device Catalogue Number: 2085
• Device Lot Number: 0022164975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 07/06/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1