MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM PVCN100; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	45010
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a loss of aspiration.A 2.1mm jetstream xc catheter and jetstream console were selected for an atherectomy procedure in the left leg tibial popliteal trunk over a non-bsc filter.The motor drive unit sounded like it was making noise, however, aspiration was lost.The motor drive quit working.When the catheter was removed from the body, the exterior was observed to be kinked and aspiration stopped.The procedure was completed with another jetstream catheter.There were no patient complications reported and the patient did well.
Event or Problem Description
It was reported that there was a loss of aspiration.A 2.1mm jetstream xc catheter and jetstream console were selected for an atherectomy procedure in the left leg tibial popliteal trunk over a non-bsc filter.The motor drive unit sounded like it was making noise, however, aspiration was lost.The motor drive quit working.When the catheter was removed from the body, the exterior was observed to be kinked and aspiration stopped.The procedure was completed with another jetstream catheter.There were no patient complications reported and the patient did well.It was further reported that the console is being used with no issues.

• Brand Name: JETSTREAM PVCN100
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10529128
• Report Number: 2134265-2020-12727
• Device Sequence Number: 3118416
• Product Code: MCW
• UDI-Device Identifier: 08714729890430
• UDI-Public: 08714729890430
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K130637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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 Model Number: 45010
• Device Catalogue Number: 45010
• Device Lot Number: JET0879
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1