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

Model Number 45007

Device Problems Entrapment of Device (1212); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2018

Event Type  malfunction  

Event Description

It was reported that the device became entrapped on the wire.A 2.1mm jetstream xc catheter and a 014 300cm thruway wire were selected for an atherectomy procedure in the superficial femoral artery (sfa).During advancement of the device, there was a lot of resistance although the vessel was opened at the proximal end.The jetstream crumbled like an accordion and became stuck on the wire.The wire was noted to be kinked distal to the tip from all the pushing.It was noted that rota glide was in the saline bag.The catheter and wire were removed together as one system.Once the devices were removed from the patient, the wire was forcefully pulled from the catheter and the wire was thrown away.The procedure was completed with a new device.There were no patient complications and the patient's status is fine.Device evaluated by mfr: returned product consisted of a jetstream xc-2.1 atherectomy catheter in one piece.Visual inspection of the device revealed no discrepancies.The shaft and the functionality of the device were investigated.Functional analysis was done by completing the set-up procedure per the directions for use (dfu) and the device primed as designed.There were no discrepancies or issues with the functionality of the device; however, there was noticeable damage in the form of buckling/kinks in 3 locations on the shaft.The locations were approximately 15cm to 20cm, 56cm to 67.5cm and 78.5cm to 83.5cm from the tip.The damage on the shaft is consistent with introducer sheath interaction.Pushing, pulling and torquing the device may possibly lead to the damage noticed.There was no guidewire returned with the device.The shaft damage reported was confirmed.Inspection of the remainder of the device, apart from the observed damage, revealed no other 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7820176
• MDR Text Key: 118399821
• Report Number: 2134265-2018-60455
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133023
• 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: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/24/2019
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0021646003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR