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

Model Number	45006
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Problem (1384); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the jetstream catheter and wire became stuck.A 1.85mm jetstream sc atherectomy catheter was selected for endovascular therapy the superficial femoral artery using contralateral approach.When advancing the catheter, the angle of the common iliac artery branch was tight and difficult to rotate the 7f destination to the contralateral side, and it was also noted there was trouble with balloon anchors.During the jetstream procedure, the rotation stopped when it was attempted to break through the stenosis where calcification was the most severe.There was no problem at the beginning of the lesion, but a lot of resistance was felt when the catheter was brought to the lesion after about 3 seconds.The jetstream also became stuck with the thruway wire, and the products had to be removed together.The procedure was completed using an another jetstream device.No patient complications were reported.

• 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: 17966281
• Report Number: 2124215-2023-58028
• Device Sequence Number: 7754328
• 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
• Report Date (Section B): 10/19/2023

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: 08/31/2025
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0032133381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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