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

Model Number	2842
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	10/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire fracture occurred and the patient experienced chest pain.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 190cm, straight-tip samurai guidewire was advanced to cross the lesion.However, during the procedure, the guidewire fractured.It took a very long time to cross the lesion, once the wire crossed the lesion the patient started having chest pain so the physician opted to continue with using the same guidewire.The wire was removed intact and no patient injury was reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Examination of the returned product showed a large curve within approximately 15 mm from the distal tip and pitch elongation of 3 wraps of the coil.
Event or Problem Description
It was reported that guidewire fracture occurred and the patient experienced chest pain.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 190cm, straight-tip samurai guidewire was advanced to cross the lesion.However, during the procedure, the guidewire fractured.It took a very long time to cross the lesion, once the wire crossed the lesion the patient started having chest pain so the physician opted to continue with using the same guidewire.The wire was removed intact and no patient injury was reported.

• Brand Name: SAMURAI
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10816643
• Report Number: 2134265-2020-15503
• Device Sequence Number: 2113919
• Product Code: DQX
• UDI-Device Identifier: 08714729881216
• UDI-Public: 08714729881216
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/19/2021

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: 02/13/2022
• Device Model Number: 2842
• Device Catalogue Number: 2842
• Device Lot Number: 0023345301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 01/19/2021
• 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