MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK JETSTREAM® XC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 112266-001

Device Problem Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device was visually examined for any shaft damage and the functionality testing of the device was completed.Functional analysis was done by completing the aspiration testing of the device.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 (100ml¿98ml = 2ml).Test results showed that this device did not perform as designed per the test procedure specification sheet withdrawing 2ml 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, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that the device stopped aspirating.A 2.4mm jetstream® xc atherectomy catheter was selected for use for a procedure in the patient's popliteal artery.The device had been used successfully for ablation of the lesion for 3 passes, 2 with blades down and 1 with blades up, but then the it stopped aspirating on the consecutive run (at the 6 minute/25 second mark).The jetstream was still activated when this issue occurred; the device continued to pump saline, but there wasn't any aspiration.No movement was observed in the tubing and no saline was dripping into the collection bag.The catheter was removed from the patient, and the physician attempted to re-prime the device, but this did not work.Another of the same device was then used to complete the procedure.No patient complications were reported.The patients condition after the procedure was good.

• Brand Name: JETSTREAM® XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7453778
• MDR Text Key: 106267902
• Report Number: 2134265-2018-03302
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2020
• Device Model Number: 112266-001
• Device Catalogue Number: PV41340
• Device Lot Number: 21712361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 90 YR