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

Model Number 45007

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

Patient Problem Embolism/Embolus (4438)

Event Date 09/04/2023

Event Type  Injury  

Event Description

It was reported that slow flow occurred.The patient presented with recurrent chronic ischemia (rutherford 6) affecting the left lower extremity with gangrene of the left heel.A left lower extremity arteriography was performed via an antegrade left common femoral artery approach, with placement of a 7 french sheath.Left lower extremity arteriography demonstrated moderate to severe calcified atherosclerotic plaque within the mid and distal superficial femoral artery (sfa) with multifocal segmental stenoses, the greatest of which was greater than 90% reduction in luminal diameter.There were two vessel runoffs via a diminutive peroneal artery (dpa) and dominant runoff to the left foot via the anterior tibial artery (at) and dorsalis pedis (dp) arteries.There was a focal significant stenosis within the distal anterior tibial artery.A jetstream sc 1.6 mm device was utilized with blades down.Subsequently, embolic protection was deployed using an 8 mm non-boston scientific device into the popliteal artery.A jetstream 2.1 mm device was utilized with blades down.A 5 mm x 100 mm ranger dcb was then utilized to treat the left sfa.Follow up arteriography of the left sfa was performed during these procedures which demonstrated an excellent angiographic result; however, the below knee segment was only evaluated after removal of the embolic protection device and after ranger dcb.This demonstrated very slow flow in both the peroneal and anterior tibial arteries with occlusion of the distal ata and dpa.The physician tried to cross the ata from an antegrade approach which was unsuccessful.He performed successful retrograde dpa access ultimately reversing the access to perform vasodilator infusion, aspiration with a standard 4 f endhole catheter (not a dedicated aspiration catheter) and 2 mm in diameter angioplasty of the ata and dpa.Final arteriography demonstrated re-established patency of the ata and dpa with relatively slow flow and no washout into the pedal arteries.Post-procedure the patient foot was cool.The patient and family did not want additional intervention to be performed.Over the next 7 days, the leg became progressively ischemic which would have indicated an amputation, which the patient and family declined.By 14 days, the toes were dusky and blistering ensued.By 21 days, worsening gangrene occurred, now progressing through the calf.The patient expired 33 days post-procedure.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18097499
• MDR Text Key: 327696627
• Report Number: 2124215-2023-60685
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0029584957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• 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