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/Embolus (4438)

Event Date 12/06/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter state: (b)(6).Initial reporter zip/post code: (b)(6).

Event Description

It was reported that an embolism occurred.The target lesion was 99% stenosed, severely calcified and located in the superficial femoral artery (sfa).Pre-dilation was performed using a balloon.Atherectomy was performed.A 1.6mm jetstream cs catheter was used first, followed by a 2.4mm jetstream xc catheter.Afterwards, in the final contrast, a distal embolism was observed.Aspiration was attempted, but it was unsuccessful.The lesion was then dilated with a non-bsc balloon and blood flow was improved on the final contrast.The procedure was completed.There were no further 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16033532
• MDR Text Key: 305983964
• Report Number: 2124215-2022-52127
• Device Sequence Number: 1
• Product Code: MCW
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0030025070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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
• Patient Age: 72 YR
• Patient Sex: Male