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

Model Number 45007

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolism (1829)

Event Date 05/22/2019

Event Type  Injury  

Event Description

It was reported that an embolism occurred.A 2.4mm jetstream xc catheter was selected for a patient femoral popliteal procedure to treat leg pain and claudication.The 2.4mm device successfully treated the intended lesion, but after its use, the physician noted that clot had embolized to the anterior tibial, posterior tibial and perineal artery.The physician believed the embolism was caused by the jetstream catheter.The physician selected a 2.1mm jetstream xc catheter to clean up the clot in the popliteal where they had previously done atherectomy, however it would not cross the lesion.The physician then opened a second 2.1mm jetstream catheter which worked fine to complete the procedure.The patient was discharged the day after the procedure.No further 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: 8650038
• MDR Text Key: 146372507
• Report Number: 2134265-2019-05965
• 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: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/29/2020
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0023260400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2019
• 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
• Patient Outcome(s): Required Intervention