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

Model Number	1920
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties and tip detachment occurred.The target lesion was located in the coronary artery.A 300cm choice guidewire was used with a non bsc stent delivery system.The choice guidewire was being withdrawn post stent placement when it became stuck to the stent's strut resulting in the guidewire's tip detachment.Removal attempts were made to retrieve the detached tip however, they were unsuccessful.The detached tip remains in vessel at proximal stent site.No patient complications were reported and the procedure concluded.
Event or Problem Description
It was reported that removal difficulties and tip detachment occurred.The target lesion was located in the coronary artery.A 300cm choice guidewire was used with a non bsc stent delivery system.The choice guidewire was being withdrawn post stent placement when it became stuck to the stent's strut resulting in the guidewire's tip detachment.Removal attempts were made to retrieve the detached tip however, they were unsuccessful.The detached tip remains in vessel at proximal stent site.No patient complications were reported and the procedure concluded.
Additional Manufacturer Narrative
Device evaluated by mfr.: device was returned for analysis.Unit returned with its original pouch.The unit returned has distal tip damaged, as part of overall visual revision.Only a guidewire was received for this complaint.The device has the distal tip damaged, it was stretched and a section of the polymer tip was detached; besides, the guidewire was kinked in different sections along its body.Dimensional inspection for overall length and outer diameter (od) of distal tip could not be performed due to device condition.Od of middle of the device and od of proximal section are within specification.

• Brand Name: CHOICE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8162329
• Report Number: 2134265-2018-64127
• Device Sequence Number: 2371165
• Product Code: DQX
• UDI-Device Identifier: 08714729150619
• UDI-Public: 08714729150619
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143587
• 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): 02/14/2019

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 Expiration Date: 10/12/2019
• Device Model Number: 1920
• Device Catalogue Number: 1920
• Device Lot Number: 0021252688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 02/14/2019
• 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