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

Model Number 112266-003

Device Problem Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of the event: 18 years or older.Device lot number: 21018260.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that there was a loss of aspiration.Jetstream® atherectomy catheter was chosen for an atherectomy procedure.During the procedure, inside of the patient, the device stopped working during 14th minute of atherectomy.Despite several attempts, the device was unable to rex or activate.No patient complications or serious injuries were reported.The patient condition after the procedure was stable.

Manufacturer Narrative

Describe event or problem: additional information.Device evaluated by mfr: returned product consisted of only a portion of the jetstream xc-2.4 atherectomy catheter.Majority of the catheter, the baton and the control pod were cut-off by the facility and not returned for analysis.The shaft, tip and blades were microscopically examined.The catheter shaft portion that was returned was measured to be 5.6cm and the tip.There was no damage to the returned portion of the shaft and tip.Functional testing could not be performed as the device was altered by the facility and not returned.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion was unable to be determined.(b)(4).

Event Description

It was further reported that the device stopped abruptly during the procedure.The physician did one pass with blades down and the device stopped working half way through the second pass with blades up.The anatomical location of the lesion being treated was the superficial femoral artery.There were no patient complications.The procedure was completed with balloons and stents.There was a metal piece stuck in the catheter tip so the catheter tip was cut for return after the procedure.Only a portion of the distal shaft/tip was sent to be returned for analysis because the remainder of the device was not suitable for return as it was heavily contaminated with blood.

• 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 MN ; EI
• MDR Report Key: 7487144
• MDR Text Key: 107357533
• Report Number: 2134265-2018-03859
• Device Sequence Number: 1
• Product Code: MCW
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2019
• Device Model Number: 112266-003
• Device Catalogue Number: PV41340
• Device Lot Number: 21098260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Date Manufacturer Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1