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

Model Number 45007

Device Problems Entrapment of Device (1212); Mechanical Problem (1384); Intermittent Loss of Power (4016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that entrapment on guidewire occurred and the device bogged down.The 70% stenosed target lesion was located in the severely tortuous and moderately calcified superficial femoral artery.A 2.4mm jetstream xc catheter was selected for revascularization.The patient had a steep bifurcation.The iliac artery was also tortuous.Difficulty occurred delivering the sheath.The jetstream was delivered over the non-boston scientific guidewire to the treatment site.Once the on button was pressed, the device began to bog down.The physician backed the device up and restarted as well as advanced it forward with the device off; however the troubleshooting techniques did not resolve the issue.The device became locked up on the guidewire and everything was pulled out of the patient intact.The procedure was completed with a drug coated balloon.Viper slide was used in our saline bag.There were no patient complications.

Manufacturer Narrative

Correction: h6: device code updated from mechanical problem to intermittent loss of power.Initial reporter facility name: (b)(6).

Event Description

It was reported that entrapment on guidewire occurred and the device bogged down.The 70% stenosed target lesion was located in the severely tortuous and moderately calcified superficial femoral artery.A 2.4mm jetstream xc catheter was selected for revascularization.The patient had a steep bifurcation.The iliac artery was also tortuous.Difficulty occurred delivering the sheath.The jetstream was delivered over the non-boston scientific guidewire to the treatment site.Once the on button was pressed, the device began to bog down.The physician backed the device up and restarted as well as advanced it forward with the device off; however the troubleshooting techniques did not resolve the issue.The device became locked up on the guidewire and everything was pulled out of the patient intact.The procedure was completed with a drug coated balloon.Viper slide was used in our saline bag.There were no patient complications.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13178695
• MDR Text Key: 283411637
• Report Number: 2134265-2021-16172
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: 08714729889922
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2023
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0027563416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male