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

Model Number	2846
Medical Device Problem Codes	Entrapment of Device (1212); Device-Device Incompatibility (2919); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the guidewire became stuck inside a guide catheter.A 190cm samurai guidewire was selected for use in a percutaneous coronary intervention (pci).Inside the patient, while introducing the guidewire through a non-boston scientific guide catheter, the tip of the guidewire went through a side hole of the guide catheter and became stuck.The guidewire was withdrawn, and it was noted that the tip had thinned and pulled apart, but it did not fully separate.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that the guidewire became stuck inside a guide catheter.A 190cm samurai guidewire was selected for use in a percutaneous coronary intervention (pci).Inside the patient, while introducing the guidewire through a non-boston scientific guide catheter, the tip of the guidewire went through a side hole of the guide catheter and became stuck.The guidewire was withdrawn, and it was noted that the tip had thinned and pulled apart, but it did not fully separate.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
A2: age at time of event - 18 years or older.Device evaluated by manufacturer: examination of the returned product showed that the coil was severely stretched starting from the solder point approximately 40mm from the distal end of the coil.The distal end was stuck together with the distal tip showing no part of the wire was lost.

• Brand Name: SAMURAI
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11449243
• Report Number: 2134265-2021-02981
• Device Sequence Number: 14465342
• Product Code: DQX
• UDI-Device Identifier: 08714729887829
• UDI-Public: 08714729887829
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: 12/15/2023
• Device Model Number: 2846
• Device Catalogue Number: 2846
• Device Lot Number: 0026525824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 05/17/2021
• 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: MEDTRONIC EBU GUIDE CATHETER; MEDTRONIC EBU GUIDE CATHETER; MEDTRONIC EBU GUIDE CATHETER