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

Model Number 45006

Device Problem Mechanical Problem (1384)

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

Event Date 09/16/2021

Event Type  malfunction  

Event Description

It was reported the blades stopped spinning during use.A jetstream 1.6 atherectomy catheter was being used during a peripheral atherectomy with percutaneous balloon angioplasty procedure treating a chronic total occluded superficial femoral artery with popliteal and post tibial lesions.The device was used over a.014 thruway wire 300cm to treat the sfa, with 2 successful passes.On the first pass of the popliteal lesion, significant resistance was felt and the device stopped working after 2 minutes of running inside the body.The physician tried to restart the device but was unsuccessful.No error messages were displayed.The device was removed and a new jetstream 1.6 was used to complete the procedure with good results.

Manufacturer Narrative

Device evaluated by mfr: the jetstream device was received by boston scientific for analysis.The shaft and the remainder of the device was inspected for damage.Visual examination showed 4 areas of damage in the form of buckling/kinks.The damage was located 13cm, 13.5cm, 15cm and 16cm 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 spin as designed.The device was functionally tested for a period of 2 minutes with no issues or errors.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities the complaint was not confirmed for blades not spinning issues; however, shaft damage was confirmed.

Event Description

It was reported the blades stopped spinning during use.A jetstream 1.6 atherectomy catheter was being used during a peripheral atherectomy with percutaneous balloon angioplasty procedure treating a chronic total occluded superficial femoral artery with popliteal and post tibial lesions.The device was used over a.014 thruway wire 300cm to treat the sfa, with 2 successful passes.On the first pass of the popliteal lesion, significant resistance was felt and the device stopped working after 2 minutes of running inside the body.The physician tried to restart the device but was unsuccessful.No error messages were displayed.The device was removed and a new jetstream 1.6 was used to complete the procedure with good results.

Event Description

It was reported the blades stopped spinning during use.A jetstream 1.6 atherectomy catheter was being used during a peripheral atherectomy with percutaneous balloon angioplasty procedure treating a chronic total occluded superficial femoral artery with popliteal and post tibial lesions.The device was used over a.014 thruway wire 300cm to treat the sfa, with 2 successful passes.On the first pass of the popliteal lesion, significant resistance was felt and the device stopped working after 2 minutes of running inside the body.The physician tried to restart the device but was unsuccessful.No error messages were displayed.The device was removed and a new jetstream 1.6 was used to complete the procedure with good results.

Manufacturer Narrative

Correction to evaluation conclusion code from adverse event related to procedure, updated to quality control deficiency.Correction was made to device evaluated by mfr: the jetstream device was received by boston scientific for analysis.Visual examination showed 4 areas of damage in the form of buckling/kinks.The damage was located 13cm, 13.5cm, 15cm and 16cm from the tip.The functionality of the device was checked by setting up the product per the instructions for use (ifu).The device primed as designed.The device was activated, and the blades did spin as designed.The device was functionally tested for a period of 2 minutes with no issues or errors.The device was rerun for a total of 4 minutes and 20 seconds.At the end of that time the gear did slid off the shaft and 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.Device analysis determined the condition of the returned device was consistent with the reported information of a blades not spinning.The complaint was confirmed for blades not spinning issues and shaft damage was confirmed.

Manufacturer Narrative

Device evaluated by mfr: the jetstream sc-1.6 device was received by boston scientific for analysis.The shaft and the remainder of the device was inspected for damage.Visual examination showed 4 areas of damage in the form of buckling/kinks.The damage was located 13cm, 13.5cm, 15cm and 16cm from the tip.The functionality of the device was checked by setting up the product per the instructions for use (ifu).The device primed as designed.The device was activated, and the blades did spin.The device was functionally tested for a period of 2 minutes with no issues or errors.The device was rerun for a period of 4 minutes and 20 seconds and the blades stopped spinning.The device control pod was opened and confirmed the gear moved off the shaft.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.Functional analysis of the device was conducted, and the device functioned for the 2-minute test.There was tip rotation.The shaft damage is consistent with the catheter being run in a tortuous anatomy and possibly a heavily stenosed calcified lesion.Pushing, pulling, and torqueing the device may also contribute to the damage on the shaft.The damage noticed may have caused stalling of the device during the procedure.

Event Description

It was reported the blades stopped spinning during use.A jetstream 1.6 atherectomy catheter was being used during a peripheral atherectomy with percutaneous balloon angioplasty procedure treating a chronic total occluded superficial femoral artery with popliteal and post tibial lesions.The device was used over a.014 thruway wire 300cm to treat the sfa, with 2 successful passes.On the first pass of the popliteal lesion, significant resistance was felt and the device stopped working after 2 minutes of running inside the body.The physician tried to restart the device but was unsuccessful.No error messages were displayed.The device was removed and a new jetstream 1.6 was used to complete the procedure with good results.

• Brand Name: JETSTREAM SC
• 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: 12594487
• MDR Text Key: 275429162
• Report Number: 2134265-2021-12068
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889830
• UDI-Public: 08714729889830
• 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,Followup,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2022
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0026171876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male