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

Model Number	2846
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that tip detachment occurred.The patient presented for provisional stenting across the left main (lm) and left anterior descending artery (lad).The 60-70% stenosed target lesion was located in the mildly tortuous and mildly calcified vessel.The first samurai guidewire crossed the lad and the second samurai the left circumflex artery (lcx).A 3.5 synergy megatron stent was deployed from the lad across the left main (lm) and an agent dcb was deployed at 6 atmospheres at the mid lcx.The megatron was then post dilated with a 4.00 x 8 non-complaint (nc) balloon at the lad and a 4.50 x 8 nc balloon at the lm.The vessel was examined using an opticross hd imaging catheter and since the lm appeared to be around 5.00mm, it was post-dilated with a 5.00 x 8 nc balloon.The opticross hd was used again, and the physician was satisfied with the results.The physician decided to remove the samurai wire from the lcx but it was snapped and 4cm remained in the vessel.A non-boston scientific wire was inserted in the lcx and a 2.00 emerge balloon advanced in an attempt to pull out the wire.The samurai remained stuck so two stents, a 3.00 x 38 and a 3.50 x 24, were implanted from the tip of the samurai wire until the ostial lcx in order to cover the wire and ensure it would not move.The opticross was run through the lcx again.No wire was seen and both stents were well apposed.No patient complications were reported.
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).The device was returned for analysis.Observation of the device revealed the core and coil were fractured at about 70 mm and 80 mm from the distal tip of the wire, respectively, and it was confirmed that the tip portion was missing.In addition, observation of the fracture surfaces of the core and coil by electron microscopy revealed twisting at the fractured ends and dimples characteristic of ductile fracture on both surfaces.
Event or Problem Description
It was reported that tip detachment occurred.The patient presented for provisional stenting across the left main (lm) and left anterior descending artery (lad).The 60-70% stenosed target lesion was located in the mildly tortuous and mildly calcified vessel.The first samurai guidewire crossed the lad and the second samurai the left circumflex artery (lcx).A 3.5 synergy megatron stent was deployed from the lad across the left main (lm) and an agent dcb was deployed at 6 atmospheres at the mid lcx.The megatron was then post dilated with a 4.00 x 8 non-complaint (nc) balloon at the lad and a 4.50 x 8 nc balloon at the lm.The vessel was examined using an opticross hd imaging catheter and since the lm appeared to be around 5.00mm, it was post-dilated with a 5.00 x 8 nc balloon.The opticross hd was used again, and the physician was satisfied with the results.The physician decided to remove the samurai wire from the lcx but it was snapped and 4cm remained in the vessel.A non-boston scientific wire was inserted in the lcx and a 2.00 emerge balloon advanced in an attempt to pull out the wire.The samurai remained stuck so two stents, a 3.00 x 38 and a 3.50 x 24, were implanted from the tip of the samurai wire until the ostial lcx in order to cover the wire and ensure it would not move.The opticross was run through the lcx again.No wire was seen and both stents were well apposed.No patient complications were reported.

• Brand Name: SAMURAI
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16535090
• Report Number: 2124215-2023-11596
• Device Sequence Number: 6042349
• Product Code: DQX
• UDI-Device Identifier: 08714729887829
• UDI-Public: 08714729887829
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 06/02/2023

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: 11/14/2025
• Device Model Number: 2846
• Device Catalogue Number: 2846
• Device Lot Number: 0030544793
• 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: 02/24/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2022
• 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: 55 YR
• Patient Sex: Male
• Patient Race: Asian