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

Model Number 45006

Device Problem Difficult or Delayed Activation (2577)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2020

Event Type  malfunction  

Event Description

It was reported that the procedure was cancelled/rescheduled post-sedation.A 1.6mm jetstream sc atherectomy catheter was selected for use to treat arterial ischemia with a severe atherosclerotic occlusion.The device was prepared for use by priming the tubing and catheter, checking for bubbles, and monitoring the system after introducing the device over the guidewire.Inside the patient, the device failed to activate.The preparation process was completed again, but the device still failed to activate.The procedure was not completed due to this event.

Manufacturer Narrative

Device evaluated by manufacturer: the returned product consisted of a jetstream atherectomy catheter.Visual and microscopic inspection was completed and found no damages.The device returned with blood present in the waste bag.The device was functionally tested by connecting it to a jetstream console.The device was able to prime and run with no issues.Inspection of the remainder of the device presented no damage or irregularities.

Event Description

It was reported that the procedure was cancelled/rescheduled post-sedation.A 1.6mm jetstream sc atherectomy catheter was selected for use to treat arterial ischemia with a severe atherosclerotic occlusion.The device was prepared for use by priming the tubing and catheter, checking for bubbles, and monitoring the system after introducing the device over the guidewire.Inside the patient, the device failed to activate.The preparation process was completed again, but the device still failed to activate.The procedure was not completed due to this event.

• Brand Name: JETSTREAM SC 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 CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 10968289
• MDR Text Key: 220225970
• Report Number: 2134265-2020-17106
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2021
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0024276974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 96 YR
• Patient Sex: Female