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 01/15/2019

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that a loss of aspiration and distal embolization occurred.A 2.1mm jetstream xc catheter was selected for an atherectomy procedure in the superficial femoral artery.During the procedure, it was noted that the return tubing was not collecting blood and a loss of aspiration occurred with distal embolization.No error message displayed.A non-bsc aspiration catheter was used to remove the debris.The procedure was completed with a drug coated balloon.No further patient complications were reported and the patient's status is fine.

Event Description

It was reported that a loss of aspiration and distal embolization occurred.A 2.1mm jetstream xc catheter was selected for an atherectomy procedure in the superficial femoral artery.During the procedure, it was noted that the return tubing was not collecting blood and a loss of aspiration occurred with distal embolization.No error message displayed.A non-bsc aspiration catheter was used to remove the debris.The procedure was completed with a drug coated balloon.No further patient complications were reported and the patient's status is fine.

Manufacturer Narrative

Age at time of event: 18 years or older.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 damage in the form a kink located 115cm from the tip.Functional analysis was done by completing the aspiration testing of the device per the test procedure.Test results showed that this device did not perform as designed per the test procedure specification withdrawing 4ml of fluid in the 1minute time frame.Inspection of the remainder of the device, revealed no damage or irregularities.Dissection of the catheter shaft showed that the aspiration lumen was occluded with a heavy clot burden which contributed to the aspiration issues.

• 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: 8307746
• MDR Text Key: 135083631
• Report Number: 2134265-2019-00793
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2020
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0022140889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Date Manufacturer Received: 02/06/2019
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: THRUWAY; GUIDEWIRE: THRUWAY; GUIDEWIRE: THRUWAY
• Patient Outcome(s): Required Intervention