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

Model Number	45006
Medical Device Problem Codes	Entrapment of Device (1212); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device became stuck on the wire.A 1.6mm jetstream sc catheter was selected for use in a leg atherectomy procedure.The target lesion was 70% stenosed with no calcification.The anatomy was tortuous to get into the pt vessel, but then it straightened out.While loading, the thruway guidewire jumped back after going through the jetstream device.Atherectomy was completed, and an attempt was made to withdraw the jetstream catheter over the wire.The jetstream became locked on the thruway guidewire.Both devices had to be pulled out together, and access was lost.A new thruway wire was opened in order to balloon the vessel, but it could not be advanced back into the vessel due to the tortuosity.Another vessel was ballooned, and the procedure was completed.No patient 2134265-2021-07255 complications were reported.

• Brand Name: JETSTREAM SC
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11946951
• Report Number: 2134265-2021-07255
• Device Sequence Number: 13718390
• Product Code: MCW
• UDI-Device Identifier: 08714729889830
• UDI-Public: 08714729889830
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2021

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: 11/11/2022
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0026505047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/07/2021
• Patient Sequence Number: 1