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

Model Number	2842
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Advance (2920)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire coating peeled off.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 190cm, straight-tip samurai guidewire was advanced but failed to cross the lesion.It was noted that the coating on the tip was peeled off.The peeled coating was only partially removed due to calcification.The procedure was completed with a different device.No patient complications were reported and patient status was stable.
Event or Problem Description
It was reported that guidewire coating peeled off.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 190cm, straight-tip samurai guidewire was advanced but failed to cross the lesion.It was noted that the coating on the tip was peeled off.The peeled coating was only partially removed due to calcification.The procedure was completed with a different device.No patient complications were reported and patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Examination of the returned product showed partial polytetrafluoroethylene (ptfe) coating was peeled off at about 225mm from the distal 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: 10235826
• Report Number: 2134265-2020-08946
• Device Sequence Number: 11549142
• Product Code: DQX
• UDI-Device Identifier: 08714729887829
• UDI-Public: 08714729887829
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151840
• 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): 10/14/2020

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: 08/12/2022
• Device Model Number: 2842
• Device Catalogue Number: 2842
• Device Lot Number: 0024260267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 10/14/2020
• 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
• Patient Age: 68 YR