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	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device became entrapped on the guidewire.This 1.85mm jetstream sc catheter was selected for use in an endovascular therapy procedure.The 50% stenosed, moderately calcified, and mildly tortuous target lesion was located in the superficial femoral artery.During the procedure, ablation of the distal sfa lesion was performed twice.Then it was attempted to remove the jetstream catheter; however, it became stuck in the non-boston scientific guidewire lumen.The devices were removed together, and the procedure was completed with another of the same device.There was no patient injury.
Event or Problem Description
It was reported that the device became entrapped on the guidewire.This 1.85mm jetstream sc catheter was selected for use in an endovascular therapy procedure.The 50% stenosed, moderately calcified, and mildly tortuous target lesion was located in the superficial femoral artery.During the procedure, ablation of the distal sfa lesion was performed twice.Then it was attempted to remove the jetstream catheter; however, it became stuck in the non-boston scientific guidewire lumen.The devices were removed together, and the procedure was completed with another of the same device.There was no patient injury.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this 1.85mm jetstream sc atherectomy catheter was returned with a non-boston scientific filter wire stuck in the device.The device and the catheter shaft were analyzed for damage.Visual examination showed no shaft damage.The non-boston scientific filter wire was sticking out of the tip approximately 29 cm, and sticking out of the pod approximately 106.5 cm.The device was set up per the instructions for use and the device primed and ran.Inspection of the remainder of the device revealed no damage or irregularities.The complaint was confirmed for guidewire sticking.Additionally, media from the clinical procedure was provided to boston scientific and was reviewed by a member of the complaint investigation site.The media review concluded: the photo returned showed the jetstream device stuck on the guidewire.

• 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: 18935747
• Report Number: 2124215-2024-15168
• Device Sequence Number: 17903069
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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: 0031965374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/23/2024
• 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