MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SAMURAI; CATHETER, GUIDEWIRE

Model Number	2846
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Chest Pain (1776); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred and remained in the patient.The target lesion was located in the non-tortuous and highly calcified distal left anterior descending artery.A 300cm, straight-tip samurai guidewire was used and 1 inch detached in the distal lad.Multiple balloons were used in this case and stenting was not successful.The patient went to surgery with chest pains.Surgery was performed but the detached tip could not be recovered.No further complications were reported and the patient status was fine.
Event or Problem Description
It was reported that tip detachment occurred and remained in the patient.The target lesion was located in the non-tortuous and highly calcified distal left anterior descending artery.A 300cm, staight-tip samurai guidewire was used and 1 inch detached in the distal lad.Multiple balloons were used in this case and stenting was not successful.The patient went to surgery with chest pains.Surgery was performed but the detached tip could not be recovered.No further complications were reported and the patient status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: as a result of examining the appearance of the returned item, it was confirmed that the core and coil were severed at a position about 6mm from the tip.

• Brand Name: SAMURAI
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10061563
• Report Number: 2134265-2020-06499
• Device Sequence Number: 16807679
• Product Code: DQX
• UDI-Device Identifier: 08714729887843
• UDI-Public: 08714729887843
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151840
• 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): 07/13/2020

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: 08/25/2022
• Device Model Number: 2846
• Device Catalogue Number: 2846
• Device Lot Number: 0024331102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 07/13/2020
• 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