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

Model Number	45006
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire entrapment occurred.The severely calcified target lesion was located in the superficial femoral artery (sfa).A 1.85mm jetstream sc catheter was selected for the atherectomy procedure.During device removal after lesion cutting by the device, it was observed that the device was entrapped on the guidewire.Both device and guidewire had to be removed together.There were no patient complications, and the case was completed with the original device.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the product was returned to boston scientific for analysis.Returned product consisted of a jetstream sc-1.85.The guidewire was in the device when returned.The device and the catheter shaft were analyzed for damage.The returned device showed shaft damage in the form of a kink located 135cm from the tip.The guidewire was pulled from the device with a slight restriction.The device was set up per the ifu and the device functioned as designed.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for guidewire sticking and shaft damage.
Event or Problem Description
It was reported that guidewire entrapment occurred.The severely calcified target lesion was located in the superficial femoral artery (sfa).A 1.85mm jetstream sc catheter was selected for the atherectomy procedure.During device removal after lesion cutting by the device, it was observed that the device was entrapped on the guidewire.Both device and guidewire had to be removed together.There were no patient complications, and the case was completed with the original 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: 18464121
• Report Number: 2124215-2023-75440
• Device Sequence Number: 7154831
• Product Code: MCW
• UDI-Device Identifier: 08714729889861
• UDI-Public: 08714729889861
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2024

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: 06/06/2025
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0031965371
• 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: 12/13/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2023
• 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
• Patient Sex: Unknown