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

Model Number 45007

Device Problems Suction Problem (2170); Material Deformation (2976)

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 was able to be further used without issue.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a jetstream xc-2.1 atherectomy catheter.The device was visually examined for any shaft damage and the functional testing of the device was completed.The device showed no damage.Functional analysis was performed by completing the setup procedure.The device functioned as designed with no issue or errors.Aspiration testing of the device was done per the test procedure.Test results showed that this device did not perform as designed per the test procedure specification sheet, withdrawing 1ml of fluid in the 1minute time frame.Inspection of the remainder of the device revealed no damage or irregularities.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10529099
• MDR Text Key: 206788846
• Report Number: 2134265-2020-12726
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• Combination Product (y/n): N
• PMA/PMN Number: K133023
• 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: 10/12/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2022
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0025783716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 10/12/2020
• Patient Sequence Number: 1