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

Model Number	2846
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire entrapment and fracture occurred while the fractured fragment remained inside the patient.The target lesion was located in the middle left circumflex (lcx) artery with 80% proximal stenosis and 50% middle stenosis.A 190cm, straight-tip samurai guidewire was placed in an obtuse marginal (om) for side branch protection for the placement of two non boston scientific (bsc) stents.After the second non-bsc stent was placed, when extracting the samurai, it got stuck under the proximal stent.The physician then used a non-bsc balloon (1.0x8mm) to protect and attempt to remove the samurai.The samurai then fractured about 4cm from the tip, which was not able to be removed.Therefore, the physician then used a bsc promus premier stent to press the fractured samurai fragment on the patient vessel wall.The procedure was completed with this device and there were no complications reported and the patient was stable.
Event or Problem Description
It was reported that guidewire entrapment and fracture occurred while the fractured fragment remained inside the patient.The target lesion was located in the middle left circumflex (lcx) artery with 80% proximal stenosis and 50% middle stenosis.A 190cm, straight-tip samurai guidewire was placed in an obtuse marginal (om) for side branch protection for the placement of two non boston scientific (bsc) stents.After the second non-bsc stent was placed, when extracting the samurai, it got stuck under the proximal stent.The physician then used a non-bsc balloon (1.0x8mm) to protect and attempt to remove the samurai.The samurai then fractured about 4cm from the tip, which was not able to be removed.Therefore, the physician then used a bsc promus premier stent to press the fractured samurai fragment on the patient vessel wall.The procedure was completed with this device and there were no complications reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: samurai, 190cm, straight-tip was returned for evaluation.Observation of the product revealed that the core was severed at about 7 mm from the distal tip.Also, at about 40mm from the distal tip, the platinum and inner stainless-steel coils were stretched in the direction of the tip and severed.The tip of the wire was missing.

• Brand Name: SAMURAI
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 13776507
• Report Number: 2134265-2022-02707
• Device Sequence Number: 17099856
• Product Code: DQX
• UDI-Device Identifier: 08714729887829
• UDI-Public: 08714729887829
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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: 09/15/2024
• Device Model Number: 2846
• Device Catalogue Number: 2846
• Device Lot Number: 0028036553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male