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	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: patient is 18 years or older.
Event or Problem Description
It was reported that the device became stuck on the guidewire.A 1.85mm jetstream sc was selected for use in a right leg angioplasty procedure.The target lesion was in the superficial femoral artery (sfa).During the procedure, the jetstream catheter became stuck on a.014 non-boston scientific guidewire in the sfa.The jetstream would still operate in 3 functions [rotations/aspiration/infusion] but would no longer move.Eventually, they were able to get the wire out.However, they could not get a new non-boston scientific guidewire back in and the entire system had to be removed.The patient did not experience any adverse events.A second device was opened, and the procedure was able to be completed.

• 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: 11362690
• Report Number: 2134265-2021-02083
• Device Sequence Number: 16405620
• Product Code: MCW
• UDI-Device Identifier: 08714729889861
• UDI-Public: 08714729889861
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/22/2021

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: 10/10/2022
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0026327259
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 02/22/2021
• Patient Sequence Number: 1