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 09/28/2021

Event Type  malfunction  

Event Description

It was reported the blades were not spinning.A 2.4mm jetstream xc catheter was used in an atherectomy treatment procedure.The patient had eccentric plaque with pronounced calcification transition located in the superficial femoral artery (sfa) to popliteal artery measuring about 10 cm.The physician performed a normal recanalization and advanced the jetstream catheter over a thruway wire.During the first pass in the lesion, the catheter was used with the blades down.It was noted the catheter background sound was a little different.The catheter was switched to rex mode and drove to the start of the eccentric lesion.A second pass in the lesion was made.During an attempt for a third pass, with the blades up, the catheter no longer started.Audibly, the motor was turning, but the blades did not rotate.No errors were seen on the console.Several attempts were made to see if the catheter would turn on again when working without blades or with blades.The thruway wire was unclamped and reclamped.Finally, the console was turned off and on again and the catheter still did not move.The catheter was replaced and the procedure was able to be completed with no patient complications.

Manufacturer Narrative

Device evaluated by mfr: the jetstream device xc-2.4 was received by boston scientific for analysis.The shaft and the remainder of the device was inspected for damage.Visual examination showed shaft damage in the form of a pinch located 116.5cm from the tip.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 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.Device analysis determined the condition of the returned device was consistent with the reported information of an unexpected shut down.The clinical observation was confirmed.

Event Description

It was reported the blades were not spinning.A 2.4mm jetstream xc catheter was used in an atherectomy treatment procedure.The patient had eccentric plaque with pronounced calcification transition located in the superficial femoral artery (sfa) to popliteal artery measuring about 10 cm.The physician performed a normal recanalization and advanced the jetstream catheter over a thruway wire.During the first pass in the lesion, the catheter was used with the blades down.It was noted the catheter background sound was a little different.The catheter was switched to rex mode and drove to the start of the eccentric lesion.A second pass in the lesion was made.During an attempt for a third pass, with the blades up, the catheter no longer started.Audibly, the motor was turning, but the blades did not rotate.No errors were seen on the console.Several attempts were made to see if the catheter would turn on again when working without blades or with blades.The thruway wire was unclamped and reclamped.Finally, the console was turned off and on again and the catheter still did not move.The catheter was replaced and the procedure was able to be completed with no patient complications.

Event Description

It was reported the blades were not spinning.A 2.4mm jetstream xc catheter was used in an atherectomy treatment procedure.The patient had eccentric plaque with pronounced calcification transition located in the superficial femoral artery (sfa) to popliteal artery measuring about 10 cm.The physician performed a normal recanalization and advanced the jetstream catheter over a thruway wire.During the first pass in the lesion, the catheter was used with the blades down.It was noted the catheter background sound was a little different.The catheter was switched to rex mode and drove to the start of the eccentric lesion.A second pass in the lesion was made.During an attempt for a third pass, with the blades up, the catheter no longer started.Audibly, the motor was turning, but the blades did not rotate.No errors were seen on the console.Several attempts were made to see if the catheter would turn on again when working without blades or with blades.The thruway wire was unclamped and reclamped.Finally, the console was turned off and on again and the catheter still did not move.The catheter was replaced and the procedure was able to be completed with no patient complications.

Manufacturer Narrative

H6, evaluation conclusion codes: previously reported as cause traced to component failure has been updated to quality control deficiency.Device evaluated by mfr: the jetstream device xc-2.4 was received by boston scientific for analysis.The shaft and the remainder of the device was inspected for damage.Visual examination showed shaft damage in the form of a pinch located 116.5cm from the tip.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 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.Device analysis determined the condition of the returned device was consistent with the reported information of an unexpected shut down.The clinical observation was confirmed.

• 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; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12579713
• MDR Text Key: 274958894
• Report Number: 2134265-2021-12408
• 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,Followup
• Report Date: 12/16/2021

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: 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: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 10/29/2021; 11/29/2021
• Supplement Dates FDA Received: 11/18/2021; 12/16/2021
• 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
• Patient Age: 74 YR
• Patient Sex: Male