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

Model Number 45007

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2020

Event Type  malfunction  

Event Description

It was reported that the coating on a wire began coming off while advancing the jetstream over the wire.A 2.4mm jetstream xc was selected for use in a runoff angiogram procedure in the superficial femoral artery (sfa).The coating on a non-boston scientific wire began coming off while attempting to advance the jetstream over the wire.The wire was exchanged for another of the same, but the same issue occurred.The jetstream was then exchanged for another of the same, but the same issue occurred.Finally, the jetstream device was flushed and the non-boston scientific wire was exchanged for a thruway.The procedure was completed.No 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 CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10976503
• MDR Text Key: 220463496
• Report Number: 2134265-2020-17112
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2022
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0025152267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MEDTRONIC SPIDER FILTER WIRE
• Patient Age: 66 YR