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

Model Number	1925
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter and guidewire entrapment occurred.After a 300 es j choice guidewire crossed the lesion, a 10.0-31 carotid wallstent was advanced for treatment.However, when the stent was attempted to be released, it was noted that the guidewire stuck within the stent system and could not be released.The wallstent delivery system and the choice guidewire were removed together and the procedure was completed with another wallstent and another guidewire.There were no patient complications nor injuries reported and the patient's condition was stable.
Event or Problem Description
It was reported that a catheter and guidewire entrapment occurred.After a 300 es j choice guidewire crossed the lesion, a 10.0-31 carotid wallstent was advanced for treatment.However, when the stent was attempted to be released, it was noted that the guidewire stuck within the stent system and could not be released.The wallstent delivery system and the choice guidewire were removed together and the procedure was completed with another wallstent and another guidewire.There were no patient complications nor injuries reported and the patient's condition was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the unit was returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The guidewire was inspected and the coating was severally damaged along the guidewire; some sections were peeled.The guidewire body was kinked approximately at 144 cm and 0.8 cm from the proximal end.No more damages were found in the device.Outer diameter of distal tip, middle of the device, and 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: 9291578
• Report Number: 2134265-2019-13478
• Device Sequence Number: 1864607
• Product Code: DQX
• UDI-Device Identifier: 08714729252290
• UDI-Public: 08714729252290
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

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: 10/19/2019
• Device Model Number: 1925
• Device Catalogue Number: 1925
• Device Lot Number: 0021277769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: CAROTID WALLSTENT; STENT: CAROTID WALLSTENT