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

Model Number 112266-001

Device Problems Entrapment of Device (1212); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of a jetstream xc-2.4 atherectomy catheter in one piece.The guidewire lumen and the catheter shaft were checked for damage.The baton and part of the aspiration tubing were cut from the device by the customer site before returning.The guidewire was not returned with the device.The device showed a severe kink in the catheter shaft approximately 23cm from the tip.A.014 test guidewire was inserted into the device and traveled as far as the kink that was noticed in the device and stopped.The kink would be consistent with the customer feeling a restriction or an indication of a guidewire sticking issue.The most likely cause of the kink was pushing, pulling and torqueing of the device.The device could not be functionally tested due to the damage.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 the catheter became stuck on the wire and the device stopped spinning during the procedure.A 2.4mm jetstream® xc atherectomy catheter and an unspecified guidewire were selected for an atherectomy procedure.During the procedure, the jetstream device stopped spinning and became stuck on the wire.The catheter and wire were removed from the patient.There were no patient complications.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the target lesion was located in the distal superficial femoral artery (sfa).The jetstream device would not work, aspirate or spin.A non-bsc wire was used.The procedure was completed with balloon angioplasty.

• 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: 7544162
• MDR Text Key: 109235655
• Report Number: 2134265-2018-04540
• 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,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2020
• Device Model Number: 112266-001
• Device Catalogue Number: PV41340
• Device Lot Number: 0021748951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2018
• 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