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

Device Problems Suction Problem (2170); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/12/2022

Event Type  malfunction  

Event Description

Jetstream china clinical study.It was reported that a loss of aspiration occurred.The subject was enrolled into the jetstream china study on (b)(6) 2022.A target lesion located in the left mid sfa had 100% occlusion with reference vessel diameter of 5.5 mm and length of 50 mm and was classified as a tasc ii b lesion.The target lesion was attempted to be treated with xc 2.1/3.0 mm jetstream catheter, however due to the performance issue noted in the console, the catheter was withdrawn, and pta was performed.The percutaneous transluminal balloon angioplasty (pta) was performed with 5.0 mm balloon, resulting into 20% final residual stenosis.On (b)(6) 2022, same day of the index procedure, console failed to aspirate during the treatment with the jetstream device.The mid-segment occlusion atherectomy of the superficial femoral artery of the left lower extremity was conducted using the jetstream system.The length of the lesion was about 50mm.At 12:44, puncture of the right femoral artery was performed, and the guide wire was passed through the lesion after crossing the superficial femoral artery of the left lower extremity, and the distal protective device was planted.A jetstream catheter was inserted into the proximal site of the target lesion through the guide wire of the protective device at 14:20.Advanced 3 times with blade off and once with blade on along with the wire without abnormal performance, the catheter model 2.1/3.1mm.Angiography showed segmental stenosis of the target lesion.There is an alarm (non-catheter alarm code) on jetstream console (serial number (b)(4)) when advancing again with the blade on model.Replaced the new catheter (model 2.1/3.1mm), the console still alarm.After pulling out the catheter for detection, the console still alarms after blade-on operation.Angiography showed that the target lesions were better than before, and the segmental residual stenosis was 80%, which was dilated with ordinary balloon, and the residual stenosis was 20% after dilated with drug-coated balloon.The blood flow was smooth, and no adverse events occurred.

Manufacturer Narrative

Initial reporter facility name: (b)(6) hospital, (b)(6) university.

Event Description

Jetstream china clinical study.It was reported that a loss of aspiration occurred.The subject was enrolled into the jetstream china study on 12-sep-2022.A target lesion located in the left mid sfa had 100% occlusion with reference vessel diameter of 5.5 mm and length of 50 mm and was classified as a tasc ii b lesion.The target lesion was attempted to be treated with xc 2.1/3.0 mm jetstream catheter, however due to the performance issue noted in the console, the catheter was withdrawn, and pta was performed.The percutaneous transluminal balloon angioplasty (pta) was performed with 5.0 mm balloon, resulting into 20% final residual stenosis.On 12-sep-2022, same day of the index procedure, console failed to aspirate during the treatment with the jetstream device.The mid-segment occlusion atherectomy of the superficial femoral artery of the left lower extremity was conducted using the jetstream system.The length of the lesion was about 50mm.At 12:44, puncture of the right femoral artery was performed, and the guide wire was passed through the lesion after crossing the superficial femoral artery of the left lower extremity, and the distal protective device was planted.A jetstream catheter was inserted into the proximal site of the target lesion through the guide wire of the protective device at 14:20.Advanced 3 times with blade off and once with blade on along with the wire without abnormal performance, the catheter model 2.1/3.1mm.Angiography showed segmental stenosis of the target lesion.There is an alarm (non-catheter alarm code) on jetstream console (serial number jet0558) when advancing again with the blade on model.Replaced the new catheter (model 2.1/3.1mm), the console still alarm.After pulling out the catheter for detection, the console still alarms after blade-on operation.Angiography showed that the target lesions were better than before, and the segmental residual stenosis was 80%, which was dilated with ordinary balloon, and the residual stenosis was 20% after dilated with drug-coated balloon.The blood flow was smooth, and no adverse events occurred.It was further reported by the site that the device deficiency was incorrectly reported, and the event did not actually occur, therefore complaint is being rescinded.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6).This supplemental report was not able to be submitted on-time by boston scientific because of delayed acknowledgments from fda for the initial report.An fda system issue resulted in the delayed acknowledgements.Boston scientific received confirmation from fda that this report will not be considered late, because it was the result of an fda system issue.

• Brand Name: JETSTREAM 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 ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15969812
• MDR Text Key: 308004163
• Report Number: 2124215-2022-40358
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 10/11/2022
• Supplement Dates FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Race: Asian