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

Model Number	2846
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that difficulty removal occurred.The target lesion was located in the left anterior descending artery.A 3.00 x 32 synergy drug-eluting stent and 300cm straight tip samurai guidewire was selected for use.However, the stent got damaged by attempting to pull off from the wire, it got stuck.The portion of the wire that got stuck was cut off.The procedure was completed with a new synergy stent.There were no patient complications reported and the patient's status was great.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.As a result of examining the appearance of the returned product, it was confirmed that the wire was cut approximately 140 mm from the proximal end while being inserted into a balloon catheter (synergy).Upon closer examination of the cut portion, it was observed that the inner lumen of the balloon catheter had accordioned, and when the accordioned portion was extended, the wire was freed and was able to be removed.Examination of the wire removed from the balloon catheter showed a white material attached to the uncoated portion.Judging from the appearance of the white material, its origin is not of this product and is presumed to have been deposited from another source.However, the identification of the white material is not known.
Event or Problem Description
It was reported that difficulty removal occurred.The target lesion was located in the left anterior descending artery.A 3.00 x 32 synergy drug-eluting stent and 300cm straight tip samurai guidewire was selected for use.However, the stent got damaged by attempting to pull off from the wire, it got stuck.The portion of the wire that got stuck was cut off.The procedure was completed with a new synergy stent.There were no patient complications reported and the patient's status was great.

• Brand Name: SAMURAI
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9687319
• Report Number: 2134265-2020-01156
• Device Sequence Number: 3350899
• Product Code: DQX
• UDI-Device Identifier: 08714729887843
• UDI-Public: 08714729887843
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 04/27/2020

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: 07/28/2022
• Device Model Number: 2846
• Device Catalogue Number: 2846
• Device Lot Number: 0024184912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 04/27/2020
• 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: 3.00 X 32 SYNERGY; STENT: 3.00 X 32 SYNERGY