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

Model Number 45010

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2020

Event Type  malfunction  

Event 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 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
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10529128
• MDR Text Key: 206789378
• Report Number: 2134265-2020-12727
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729890430
• UDI-Public: 08714729890430
• Combination Product (y/n): N
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45010
• Device Catalogue Number: 45010
• Device Lot Number: JET0879
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1