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 11/11/2019

Event Type  malfunction  

Event Description

It was reported that the catheter stuck on the wire.The 100% stenosed target lesion was approximately 220 mm long chronic total occlusion (cto), located in the heavily tortuous and mildly calcified superficial femoral artery.A 2.1mm jetstream xc atherectomy catheter was selected for an atherectomy procedure within the sfa.Upon withdrawal of the device, it became stuck on the guidewire and it could not be removed.The catheter and the wire were removed together from the patient.The procedure was successfully completed with percutaneous transluminal angioplasty (pta) and stenting as planned.There were no patient complications and the patient's status was fine post procedure.

Event Description

It was reported that the catheter stuck on the wire.The 100% stenosed target lesion was approximately 220 mm long chronic total occlusion (cto), located in the heavily tortuous and mildly calcified superficial femoral artery.A 2.1mm jetstream xc atherectomy catheter was selected for an atherectomy procedure within the sfa.Upon withdrawal of the device, it became stuck on the guidewire and it could not be removed.The catheter and the wire were removed together from the patient.The procedure was successfully completed with percutaneous transluminal angioplasty (pta) and stenting as planned.There were no patient complications and the patient's status was fine post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of a jetstream xc-2.1 atherectomy catheter with the guidewire was returned stuck in the device.The device and the catheter shaft were analyzed for damage.Visual analysis showed no damage on the shaft.Functionality testing was completed and the device functioned as designed.Dissection of the tip showed that the bushing was occluded with coating from the guidewire shaft.The jetstream device dfu lists the compatible guidewire that are to be used with the jetstream device.The guidewire that was used during this procedure was not on the compatible list.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: 9378762
• MDR Text Key: 174185192
• Report Number: 2134265-2019-14496
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0023371328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR