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

Model Number 45007

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: event date was not reported and was approximated to (b)(6) 2020.

Event Description

It was reported that the device became stuck on the wire, requiring additional intervention to remove.A 2.4mm jetstream xc was selected for use in an atherectomy procedure in the superficial femoral artery.After performing atherectomy, an attempt was made to remove the device over the non-boston scientific guidewire, but the devices became stuck together.The jetstream was unable to be removed.Therefore, the device was cut with scissors and removed.The guidewire was noted to have been accidentally kinked.No patient complications were reported.

Event Description

It was reported that the device became stuck on the wire, requiring additional intervention to remove.A 2.4mm jetstream xc was selected for use in an atherectomy procedure in the superficial femoral artery.After performing atherectomy, an attempt was made to remove the device over the non-boston scientific guidewire, but the devices became stuck together.The jetstream was unable to be removed.Therefore, the device was cut with scissors and removed.The guidewire was noted to have been accidentally kinked.No patient complications were reported.It was further reported that the guidewire entrapment occurred when the jetstream during removal from the sheath.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis without the guidewire.The catheter shaft showed extreme damage, including a separated shaft.There was buckling and kinks throughout the shaft.The functionality of the device could not be completed due to the damage on the device.Inspection of the remainder of the device revealed no other damage or irregularities.The device was confirmed for guidewire sticking due to the extreme damage on the shaft.

Event Description

It was reported that the device became stuck on the wire, requiring additional intervention to remove.A 2.4mm jetstream xc was selected for use in an atherectomy procedure in the superficial femoral artery.After performing atherectomy, an attempt was made to remove the device over the non-boston scientific guidewire, but the devices became stuck together.The jetstream was unable to be removed.Therefore, the device was cut with scissors and removed.The guidewire was noted to have been accidentally kinked.No patient complications were reported.It was further reported that the guidewire entrapment occurred when the jetstream during removal from the sheath.

• 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: 10860897
• MDR Text Key: 216880288
• Report Number: 2134265-2020-16021
• Device Sequence Number: 1
• Product Code: MCW
• 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,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2022
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0025959034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 12/10/2020
• Patient Sequence Number: 1
• Treatment: CSI VIPERWIRE; CSI VIPERWIRE; CSI VIPERWIRE; CSI VIPERWIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR