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

Model Number 45007

Device Problems Mechanical Problem (1384); Difficult to Advance (2920); Unexpected Shutdown (4019)

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

Event Date 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

Device eval by mfr: the jetstream device xc-2.4 was received by boston scientific for analysis.Visual examination showed two kinks located 1cm and 1.5cm from the tip.There was blood in the aspiration line.The functionality of the device was checked by setting up the product per the ifu.The device primed as designed.The device was activated, and the blades did not spin as designed.The devices motor was heard; however, no tip rotation was noticed.The devices pod was opened to inspect for damage.It was noticed the pinion gear had slipped off the drive shaft.When the gear slides off the shaft and does not contact the motor gear, rotation of the tip would stop.The gear was removed and inspected.Adhesive was present on the gear as designed.

Event Description

It was reported that the blades lost rotation.A 2.4mm jetstream catheter was selected for use to treat peripheral artery disease (pad) in the mid superficial femoral artery (sfa).The target lesion was 60-70% stenosed, mildly tortuous and moderately calcified.The device was advanced through the lesion in both blades down and blades up mode.During treatment of the lesion, significant resistance was noted and the blades stopped spinning.The rotation could not be reactivated.The device was removed and a new jetstream was used to complete the procedure.There were no patient complications.

Event Description

It was reported that the blades lost rotation.A2.4mm jetstream catheter was selected for use to treat peripheral artery disease (pad) in the mid superficial femoral artery (sfa).The target lesion was 60-70% stenosed, mildly tortuous and moderately calcified.The device was advanced through the lesion in both blades down and blades up mode.During treatment of the lesion, significant resistance was noted and the blades stopped spinning.The rotation could not be reactivated.The device was removed and a new jetstream was used to complete the procedure.There were no patient complications.

Manufacturer Narrative

Corrected device eval by mfr: the jetstream device xc-2.4 was received by boston scientific for analysis.Visual examination showed 1 kink located 1cm from the tip and multiple small bends and kinks located from the tip to 16.5cm proximal.The functionality of the device was checked by setting up the product per the instructions for use.The device primed as designed.The device was activated, and the blades did spin as designed.The pod cover was removed, and the pinion gear was viewed for movement.The device was functionally tested for a period of 2 minutes with no issues or errors.No movement of the pinion gear was noticed, and the pinion gear was secure to the shaft.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• 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 IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12780315
• MDR Text Key: 280532239
• Report Number: 2134265-2021-13922
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2023
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0027563417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Race: White