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

Model Number 45007

Device Problems Suction Problem (2170); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2020

Event Type  malfunction  

Event Description

It was reported that aspiration was lost.A 2.4mm jet stream xc catheter was selected for an atherectomy procedure to treat in-stent restenosis in the superficial femoral artery (sfa).The majority of the larger than 300cm stented segment was treated in blades down mode.While advancing the catheter to treat a 2cm segment of restenosis in blades up mode, aspiration began to slow, and then was lost.The catheter blades continued to rotate.The catheter was removed from the patient and re-primed.Aspiration appeared to be better.During insertion into the patient, the catheter was difficult to track over the non-bsc wire.A new device was then used to complete the procedure.There were no patient complications.

Manufacturer Narrative

Device analysis by mfr: the device was visually examined for any shaft damage and the functional testing of the device was completed.The device showed a kink located 56.5cm from the tip.A.014 test guidewire was used to insert into the lumen.The wire encountered a slight restriction at the kinked area.Functional analysis was done by completing the setup procedure per the ifu.Aspiration testing of the device was done per the test procedure.The device is tested by using a 100ml beaker of water.The devices tip is submerged in a beaker of fluid and the device is run for a period of 1 minute.The final milliliters of fluid that the beaker shows after the 1minute run time is subtracted from the starting milliliters and the final number is the total that was aspirated.Test results showed that this device did not perform as designed per the test procedure specification sheet withdrawing 4ml of fluid in the 1minute time frame.Inspection of the remainder of the device revealed no damage or irregularities.

Event Description

It was reported that aspiration was lost.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure to treat in-stent restenosis in the superficial femoral artery (sfa).The majority of the larger than 300cm stented segment was treated in blades down mode.While advancing the catheter to treat a 2cm segment of restenosis in blades up mode, aspiration began to slow, and then was lost.The catheter blades continued to rotate.The catheter was removed from the patient and re-primed.Aspiration appeared to be better.During insertion into the patient, the catheter was difficult to track over the non-bsc wire.A new device was then used to complete the procedure.There were no patient complications.

• 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: 10695554
• MDR Text Key: 211856752
• Report Number: 2134265-2020-14270
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: 08714729889922
• 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: 11/11/2020

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: 06/28/2022
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0025778633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 11/10/2020
• Supplement Dates FDA Received: 11/11/2020
• Patient Sequence Number: 1
• Treatment: ABBOTT NAV 6 FILTERWIRE AND BARE WIRE.; ABBOTT NAV 6 FILTERWIRE AND BARE WIRE.; ABBOTT NAV 6 FILTERWIRE AND BARE WIRE
• Patient Age: 96 YR