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

Model Number 45007

Device Problems Entrapment of Device (1212); Difficult to Advance (2920)

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

Event Date 11/09/2021

Event Type  malfunction  

Event Description

It was reported that the device became entrapped on the wire.A 2.1mm jetstream xc catheter was selected for a left lower extremity runoff procedure for peripheral artery disease in the superficial femoral artery (sfa).The lesion had mild calcification, mild tortuosity, and was a chronic total occlusion.During the procedure the device had some issues tracking/crossing the sfa lesion.Once several passes were made physician attempted to remove the device, but it would not come off of the non-bsc wire.They attempted to rex and advance the device to loosen it from the wire without success.Finally had to remove everything as one unit out of the patient and then recross lesion.No visible damage was noted on the device.Procedure completed successfully with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the returned product consisted of a jetstream xc 2.1.A non-compatible filter wire was stuck in the device.The device and the catheter shaft were analyzed for damage.The guidewire was in the device when received and analyzed.The catheter shaft showed multiple areas of buckling located 1cm, 88.5cm and 89.5cm from the tip.A severe kink was noticed approximately 55cm from the tip.The guidewire showed scraped coating at the tip.The guidewire tip was protruding from the distal end of the device 9.5cm and from the proximal end of the device 154.5cm.The device was set up per the instructions for use.The device primed and functioned intermittently due to the shaft damage.During the functional test, the gear slid off the shaft within 20 seconds of functionally testing.The blades stopped spinning.The pod was opened and confirmed the failure of the gear sliding off the shaft.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The jetstream device instructions for use lists the compatible guidewires that are to be used with the jetstream device.The guidewire that was used during this procedure was not on the compatible list.The wire used was a spider.014 filter guidewire.Use of any non-compatible guidewire may compromise performance or damage to the jetstream system.Compatible guidewires: jetwire 0.014 in 0.36 mm 300 cm.Thruway 0.014 in 0.36 mm 300 cm.Abbott vascular hi-torque spartacore.Abbott vascular hi-torque iron man.

Event Description

It was reported that the device became entrapped on the wire.A 2.1mm jetstream xc catheter was selected for a left lower extremity runoff procedure for peripheral artery disease in the superficial femoral artery (sfa).The lesion had mild calcification, mild tortuosity, and was a chronic total occlusion.During the procedure the device had some issues tracking/crossing the sfa lesion.Once several passes were made physician attempted to remove the device, but it would not come off of the non-bsc wire.They attempted to rex and advance the device to loosen it from the wire without success.Finally had to remove everything as one unit out of the patient and then recross lesion.No visible damage was noted on the device.Procedure completed successfully with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the returned product consisted of a jetstream xc 2.1.A non-compatible filter wire was stuck in the device.The device and the catheter shaft were analyzed for damage.The guidewire was in the device when received and analyzed.The catheter shaft showed multiple areas of buckling located 1cm, 88.5cm and 89.5cm from the tip.A severe kink was noticed approximately 55cm from the tip.The guidewire showed scraped coating at the tip.The guidewire tip was protruding from the distal end of the device 9.5cm and from the proximal end of the device 154.5cm.The device was set up per the instructions for use.The device primed and functioned intermittently due to the shaft damage.During the functional test, the gear slid off the shaft within 20 seconds of functionally testing.The blades stopped spinning.The control pod was opened and confirmed the failure of the gear sliding off the shaft.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The jetstream device instructions for use lists the compatible guidewires that are to be used with the jetstream device.The guidewire that was used during this procedure was not on the compatible list.The wire used was a spider.014 filter guidewire.Use of any non-compatible guidewire may compromise performance or damage to the jetstream system.Compatible guidewires: jetwire 0.014 in 0.36 mm 300 cm.Thruway 0.014 in 0.36 mm 300 cm.Abbott vascular hi-torque spartacore.Abbott vascular hi-torque iron man.

• 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: 12905588
• MDR Text Key: 281517023
• Report Number: 2134265-2021-14620
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2023
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0028057459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: SPIDER RX 5.0 - MEDTRONIC; GUIDEWIRE: SPIDER RX 5.0 - MEDTRONIC
• Patient Sex: Female
• Patient Race: White