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

Model Number	2842
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered.A 190cm, j-tip samurai guidewire was advanced to cross the lesion.However, it was noted that the guidewire was entangled and was trapped within the lesion.It was not specified how the guidewire was removed.No patient complications were reported.
Event or Problem Description
It was reported that removal difficulties were encuntered.A 190cm, j-tip samurai guidewire was advanced to cross the lesion.However, it was noted that the guidewire was entangled and was trapped within the lesion.It was not specified how the guidewire was removed.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: examination of the returned product showed a curve along the length of approximately 50 mm from the distal tip and another one at about 200 mm 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: 9335475
• Report Number: 2134265-2019-13864
• Device Sequence Number: 2616231
• Product Code: DQX
• UDI-Device Identifier: 08714729881223
• UDI-Public: 08714729881223
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K151840
• 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): 06/15/2020

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: 12/09/2021
• Device Model Number: 2842
• Device Catalogue Number: 2842
• Device Lot Number: 0023044307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 06/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR