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

Model Number 45007

Device Problem Suction Problem (2170)

Patient Problem Embolism (1829)

Event Date 04/23/2019

Event Type  Injury  

Event Description

It was reported that the device lost aspiration.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure in the left popliteal artery.The device primed with no issue.During the procedure, the jetstream catheter partially lost aspiration.The device was removed and re-flushed, re-primed and put back in.The catheter was still losing aspiration, embolism was noted, and bubbles of air were noted in the device.Another jetstream device was selected and the procedure was completed.The distal emboli was aspirated with this second device.There were no further patient complications were reported and the patient is fine.

Event Description

It was reported that the device lost aspiration.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure in the left popliteal artery.The device primed with no issue.During the procedure, the jetstream catheter partially lost aspiration.The device was removed and re-flushed, re-primed and put back in.The catheter was still losing aspiration, embolism was noted, and bubbles of air were noted in the device.Another jetstream device was selected and the procedure was completed.The distal emboli was aspirated with this second device.There were no further patient complications were reported and the patient is fine.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a jetstream xc-2.4 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 completed.Test results showed that this device did not perform as designed per the test procedure specification sheet, withdrawing 1 ml of fluid in the 1-minute time frame.Dissection of the catheter shaft showed that the aspiration lumen was occluded with a heavy clot burden which contributed to the aspiration issues.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: 8573978
• MDR Text Key: 143844050
• Report Number: 2134265-2019-04729
• 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: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0023365000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention