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

Model Number 45007

Device Problem Entrapment of Device (1212)

Patient Problem Embolism (1829)

Event Date 06/17/2019

Event Type  Injury  

Event Description

It was reported that the device became stuck on the wire and the patient incurred distal embolic material.A 2.4 mm jetstream xc catheter was selected for an atherectomy procedure in the superficial femoral artery (sfa).A 65 cm non-bsc 7fr sheath was placed over the bifurcation of the sfa.A 315 cm non-bsc guidewire and a non-bsc filter wire were placed distal of the popliteal artery due to the presence of thrombus.An angiogram was taken post-filter wire deployment.No embolic material was noted at that point.The jetstream catheter was advanced over the 315 cm non-bsc guidewire.While operating, the device did not stall and was advanced at 1 mm per second.After 123 seconds of runtime, the tip of the jetstream catheter became stuck on the guidewire.The physician chose to remove the jetstream system with the wire as one and then disposed the device.After removal, a distal emboli was discovered.The physician concluded the distal emboli was a direct result of the device becoming stuck on the wire.The distal emboli embolized to the tibial perioneal trunk.The physician implanted a stent to cover the embolus.The patient was successfully treated and was in stable condition post-procedure.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8785541
• MDR Text Key: 150856212
• Report Number: 2134265-2019-07550
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2020
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0023089009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7 FR TERUMO DESTINATION SHEATH 65 CM; ABBOTT 315 BAREWIRE; ABBOTT NAV6 FILTERWIRE
• Patient Outcome(s): Required Intervention