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

Model Number 45007

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2020

Event Type  malfunction  

Event Description

It was reported a loss of aspiration occurred during use.A 2.4mm jetstream xc catheter was selected for use in an atherectomy procedure in the left superficial femoral artery.Three passes were performed through the in-stent restenosis (isr) then the system stopped aspirating.A balloon and stent were used to complete the procedure.There were no patient complications.

Manufacturer Narrative

Device analysis by mfr: the returned product consisted of a jetstream xc 2.4 atherectomy catheter.The device showed no damage.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 7ml of fluid in the 1minute time frame.Inspection of the remainder of the device, revealed no damage or irregularities.

Event Description

It was reported a loss of aspiration occurred during use.A 2.4mm jetstream xc catheter was selected for use in an atherectomy procedure in the left superficial femoral artery.Three passes were performed through the in-stent restenosis (isr) then the system stopped aspirating.A balloon and stent were 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: 9727647
• MDR Text Key: 180394407
• Report Number: 2134265-2020-01694
• 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: 03/02/2020

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: 05/24/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0023998191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 02/20/2020
• Supplement Dates FDA Received: 03/02/2020
• Patient Sequence Number: 1
• Patient Age: 81 YR