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

Model Number 45006

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2018

Event Type  malfunction  

Event Description

It was reported that the jetstream catheter became stuck on the non-bsc wire.A 1.6 mm jetstream catheter was selected for a procedure in the superficial femoral artery (sfa).During the procedure, the catheter would not track appropriately over the non-bsc filter wire.The device was removed and the procedure was completed with a different device.There were no patient complications reported and the patient's status post procedure was fine.Returned product consisted of a jetstream sc-1.6 atherectomy catheter.The device and the catheter shaft were analyzed for damage.The guidewire was not stuck or returned with the device.Visual analysis showed that the device showed damage in the form of 2 kinks on the shaft.The 1st kink was located 1.3cm from the tip and the 2nd kink was located 20.5cm from the tip.A thruway test guidewire was attempted to be put into the device.The wire would not go past the tip area.The tip was removed from the catheter shaft and the internal area of the tip was occluded with guidewire coating from the spider wire that the customer intended to use.It was noticed per the customers returned statement that the guidewire used during the procedure was a spider filter wire.This wire is not on the compatible guidewire list.If the customer site used a non-compatible guidewire they may experience guidewire or device performance issues.Functionality testing was completed by connecting the device to the jetstream console.The device ran as designed with no issues or errors.Inspection of the remainder of the device, revealed no damage or irregularities.

• Brand Name: JETSTREAM SC
• 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: 8078984
• MDR Text Key: 127550687
• Report Number: 2134265-2018-62940
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889830
• UDI-Public: 08714729889830
• 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: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2020
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0022317157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1