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

Model Number 45007

Device Problems Entrapment of Device (1212); Material Twisted/Bent (2981)

Patient Problem Thrombosis (2100)

Event Date 12/10/2018

Event Type  Injury  

Event Description

It was reported that the device stuck on the wire and thrombosis occurred. A 2. 1mm jetstream xc atherectomy catheter was selected for use in an atherectomy procedure. During the procedure inside the patient's body, the device crossed. Upon finishing the procedure, the device stuck a bit and some wire was lost as the device was pulled out and it was noted that the catheter partly wrinkled on itself at the tip. The patient was hospitalized due to some clot that formed in the previously placed stent. No further patient complications were reported.

• 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 CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8171088
• MDR Text Key: 130553145
• Report Number: 2134265-2018-64408
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/05/2020
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0022756971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2018
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial