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 12/15/2020

Event Type  malfunction  

Event Description

It was reported that the device became stuck on the guidewire.A 2.4mm jetstream xc was selected for use in an atherectomy and percutaneous transluminal angioplasty procedure in the left leg's superficial femoral artery.The 80% stenosed target lesion was moderately calcified and located in mildly tortuous anatomy.Prior to the procedure, the thruway guidewire was noted to be kinked, but it was used anyway.During insertion, the jetstream xc became stuck on the guidewire, and both devices had to be removed as a system.The procedure was completed with another of the same device.No patient complications were reported.The patient did fine post-procedure.

Manufacturer Narrative

Device eval by manufacturer: the product was returned to boston scientific for analysis.Returned product consisted of a jetstream xc-2.4.The guidewire was not in the device or returned with the device.The device and the catheter shaft were analyzed for damage.The catheter shaft showed multiple areas of buckling from the tip to proximal 47cm.A severe kink was noticed 1cm from the tip.The device was set up per the instructions for use and the device primed and functioned as designed.A 0.014 inch thruway test guidewire was inserted into the guidewire lumen of the device and the wire transcended through the shaft until it stopped approximately 43cm from the tip due to the shaft damage.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint was confirmed for a restriction on the guidewire due to the damage on the catheter shaft.

Event Description

It was reported that the device became stuck on the guidewire.A 2.4mm jetstream xc was selected for use in an atherectomy and percutaneous transluminal angioplasty procedure in the left leg's superficial femoral artery.The 80% stenosed target lesion was moderately calcified and located in mildly tortuous anatomy.Prior to the procedure, the thruway guidewire was noted to be kinked, but it was used anyway.During insertion, the jetstream xc became stuck on the guidewire, and both devices had to be removed as a system.The procedure was completed with another of the same device.No patient complications were reported.The patient did fine post-procedure.

• 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: 11066325
• MDR Text Key: 223442586
• Report Number: 2134265-2020-18371
• 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: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2022
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0026308142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 01/07/2021
• Patient Sequence Number: 1
• Patient Age: 73 YR