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

Model Number 45007

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2018

Event Type  malfunction  

Event Description

It was reported that a device became stuck on a wire.A 2.4 mm jetstream xc catheter was selected for an atherectomy procedure in the left superficial femoral artery.At the end of the procedure during removal of the device, the jetstream because stuck on a non-bsc wire.Both the jetstream and non-bsc wire were able to be removed without complication.The patient experienced no harm or adverse events.

Event Description

It was reported that a device became stuck on a wire.A 2.4 mm jetstream xc catheter was selected for an atherectomy procedure in the left superficial femoral artery.At the end of the procedure during removal of the device, the jetstream because stuck on a non-bsc wire.Both the jetstream and non-bsc wire were able to be removed without complication.The patient experienced no harm or adverse events.

Manufacturer Narrative

Device eval by manufacturer: returned product consisted of a jetstream xc-2.4 atherectomy catheter with a.014 nav 6 filter wire stuck in the device.The device and the catheter shaft were analyzed for damage.Visual analysis showed 1 kink on the catheter shaft located 101.5cm from the tip.Functionality was completed by connecting the device to the jetstream console.The device functioned as designed.The customer stated that a nav 6 filter wire was used for this procedure which is not on the compatible guidewire list per the dfu.Microscopic analysis of the tip area showed that the device had been run over the coils of the guidewire.When the device is run too far distal and interference with the coils results, this could contribute to the guidewire sticking issues the customer experienced.Inspection of the remainder of the device, revealed no 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
• MDR Report Key: 8169708
• MDR Text Key: 130531803
• Report Number: 2134265-2018-64103
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: 08714729889922
• Combination Product (y/n): N
• PMA/PMN Number: K133023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2020
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0022756974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 12/21/2018
• Supplement Dates FDA Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NAV6 WIRE; NAV6 WIRE; NAV6 WIRE