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

Model Number 45007

Device Problem Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

Device eval by manufacturer: the 2.1mm jetstream xc was received and device was inspected for damage.Visual examination showed severe shaft damage from the proximal tip to 5cm.The devices shaft and infusion line were stretched, broken and peeled away.The device was not completely separated and the drive coil was connected.The functionality of the device was checked by setting up the product per the instructions for use.The device was primed, activated, and the blades spun at a very slow speed, due to the severe damage on the shaft.Apart from the noted damage, no other damage or irregularities were observed.The condition of the returned device was consistent with the reported information of an unexpected shut down.

Event Description

Reportable based on device analysis completed on 23feb2021.It was reported that, while in use, the jetstream system stopped all activity.A 2.1mm jetstream xc was selected for use in a peripheral intervention procedure.While in use the jetstream system stopped all activity.The healthcare professional tried to troubleshoot and could not get the device to work.There were no device defects noted.A second device was opened and there were no further issues.There were no patient complications and the patient went home that evening.However, device analysis revealed severe shaft damage.

• 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: 11496167
• MDR Text Key: 240117632
• Report Number: 2134265-2021-03368
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• 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: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0024570150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2019
• 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