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

Model Number 45007

Device Problem Mechanical Problem (1384)

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

Event Date 09/29/2021

Event Type  malfunction  

Event Description

It was reported that blade rotation was lost.The target lesion was located in the left superficial femoral artery (fsa).A 2.4mm jetstream xc atherectomy catheter was in use for atherectomy and lost rotation, in the second pass.The catheter would not work in high speed.The catheter was switched to rex mode; however, the rotation was slow.The catheter was removed and the procedure was completed with a new jetstream.There were no patient complications.

Manufacturer Narrative

Device eval by mfr: the jetstream device xc 2.4 was received for analysis.The shaft and the remainder of the device was inspected for damage.Visual examination showed no shaft damage.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 pinion gear slides off the shaft and does not contact the motor gear, rotation of the tip would stop.The gear was slid back on the shaft and the device was activated; however, the blades still did not spin which is an indication of the gear slipping on the shaft.

Event Description

It was reported that blade rotation was lost.The target lesion was located in the left superficial femoral artery (fsa).A 2.4mm jetstream xc atherectomy catheter was in use for atherectomy and lost rotation, in the second pass.The catheter would not work in high speed.The catheter was switched to rex mode; however, the rotation was slow.The catheter was removed and the procedure was completed with a new jetstream.There were no patient complications.

• Brand Name: JETSTREAM XC 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 IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12575898
• MDR Text Key: 274715036
• Report Number: 2134265-2021-12363
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/14/2021

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: 06/30/2023
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0027755154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 11/29/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1