MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM SC; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	45006
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was stuck on the guidewire.The 95% stenosed, severely calcified and moderately tortuous target lesion was located in the right superficial femoral artery (sfa).A 1.6 mm jetstream xc catheter was selected for an atherectomy procedure.The device was stuck on a non-bsc guidewire.The device had to be removed together with the guidewire.No patient complications were reported.The procedure was completed with a different device.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the returned device is a jetstream atherectomy catheter with an unknown wire inside the device.The device was visually and microscopically examined for any damage.Visual examination and microscopic examination revealed no damages.The returned guidewire was able to be removed without any resistance.Testing was performed by inserting the returned guidewire through the device.It was able to pass through without any issues.A test guidewire was also used and was able to pass through without any issues.Inspection of the remainder of the device, revealed no damage or irregularities.Product analysis could not confirm the reported stuck on wire but did find information in the ifu suggesting that the noncompatible guidewire was used which could have contributed to the reported event.
Event or Problem Description
It was reported the device was stuck on the guidewire.The 95% stenosed, severely calcified and moderately tortuous target lesion was located in the right superficial femoral artery (sfa).A 1.6 mm jetstream xc catheter was selected for an atherectomy procedure.The device was stuck on a non-bsc guidewire.The device had to be removed together with the guidewire.No patient complications were reported.The procedure was completed with a different device.

• Brand Name: JETSTREAM SC
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19522356
• Report Number: 2124215-2024-35804
• Device Sequence Number: 6081006
• Product Code: MCW
• UDI-Device Identifier: 08714729889830
• UDI-Public: 08714729889830
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: 09/19/2024
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0030386081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASAHI INTECC CRUISE GUIDEWIRE.; ASAHI INTECC CRUISE GUIDEWIRE.
• Patient Sex: Unknown