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

Model Number 45006

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Obstruction/Occlusion (2422); Embolism/Embolus (4438)

Event Date 11/07/2022

Event Type  Injury  

Event Description

It was reported an occlusion occurred due to distal embolism post-ablation procedure.Initial ivus imaging, on the day of the procedure, determined it would be too difficult to cross this lesion with a balloon catheter, thus two different sized jetstream catheters were selected for use in this atherectomy procedure for treatment of chronic limb-threatening ischemia and ulceration on the left fifth artery.The target lesion was in the left superficial femoral artery (sfa), which was 99% stenosed with severe calcification on both sides and mild tortuosity.Initial ablation of the lesion was performed using a jetstream sc 1.6mm catheter.During the ablation the speed was slow, the sound did not change, the blade continued rotating, and the lesion was able to cross.A second ablation was performed using a jetstream xc 2.4/3.4mm catheter.During the first pass, using 2.4mm (blade down), the catheter was able to cross the lesion without any problem.The same catheter was again used for a second pass with 3.4mm (blade up).The ablation speed was still slow and changes on sound/outflow were not observed.After the three ablation passes, fluoroscopy below the knee was performed to compare the flow pre and post procedure, where it was determined that there was an occlusion in the left 3rd, 4th, and 5th major arteries.When compared to the angiographic image before the procedure, flow speed was slow before the procedure, but occlusion was observed after ablation.The left lower leg also became blue tone.An act was checked to rule out thrombotic occlusion, but there was no problem with 300sec range.The physician deemed that a distal embolism occurred and administered 10mg of papaverine in three doses of 4mg, 3mg and 3mg.The response was poor at first, but after administering a total of 10mg, both the 4th and 5th major arteries were confirmed to have blood flow, however, not good as before the procedure.Since the blue tone on the lower leg also reduced, the procedure was completed, and follow-up observation was performed.

Event Description

It was reported an occlusion occurred due to distal embolism post-ablation procedure.Initial ivus imaging, on the day of the procedure, determined it would be too difficult to cross this lesion with a balloon catheter, thus two different sized jetstream catheters were selected for use in this atherectomy procedure for treatment of chronic limb-threatening ischemia and ulceration on the left fifth artery.The target lesion was in the left superficial femoral artery (sfa), which was 99% stenosed with severe calcification on both sides and mild tortuosity.Initial ablation of the lesion was performed using a jetstream sc 1.6mm catheter.During the ablation the speed was slow, the sound did not change, the blade continued rotating, and the lesion was able to cross.A second ablation was performed using a jetstream xc 2.4/3.4mm catheter.During the first pass, using 2.4mm (blade down), the catheter was able to cross the lesion without any problem.The same catheter was again used for a second pass with 3.4mm (blade up).The ablation speed was still slow and changes on sound/outflow were not observed.After the three ablation passes, fluoroscopy below the knee was performed to compare the flow pre and post procedure, where it was determined that there was an occlusion in the left 3rd, 4th, and 5th major arteries.When compared to the angiographic image before the procedure, flow speed was slow before the procedure, but occlusion was observed after ablation.The left lower leg also became blue tone.An act was checked to rule out thrombotic occlusion, but there was no problem with 300sec range.The physician deemed that a distal embolism occurred and administered 10mg of papaverine in three doses of 4mg, 3mg and 3mg.The response was poor at first, but after administering a total of 10mg, both the 4th and 5th major arteries were confirmed to have blood flow, however, not good as before the procedure.Since the blue tone on the lower leg also reduced, the procedure was completed, and follow-up observation was performed.Additional information indicated that the day after the initial ablation procedure ((b)(6)2022), the color condition was quite limited and the angio test has not been performed, but the condition was improving overall.Postoperative cardiac function was poor, and the patient was transferred to the intensive care unit for management (icu).Although the official date was unknown, pci (percutaneous coronary intervention) and cabg (coronary artery bypass graft) were performed during that time in the icu, which was able to stabilize the circulatory dynamics.The patient was discharged home on (b)(6) 2023; however, was found dead at home on (b)(6) 2023.The doctor reported that the police had intervened.The cause of death remains unknown; however, it was believed that there was no causal relationship with treatment.

• 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 ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15925610
• MDR Text Key: 304913263
• Report Number: 2124215-2022-50147
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889830
• UDI-Public: 08714729889830
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0029879873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention