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 Pain (1994); Embolism/Embolus (4438)

Event Date 10/06/2023

Event Type  Injury  

Event Description

It was reported that slow flow occurred requiring amputation.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa).A 2.4mm jetstream xc, 1.85mm jetstream sc and a ranger balloon were selected for use.While using the sc 1.85, which worked as intended, it almost got stuck, but by fixing the tip of the catheter in place, the resistance was relieved, and it was possible to continue using it as before.Treatment was started from the right groin in an ipsilateral antegrade direction.The sfa lesion was passed easily with a 0.035 inch guide wire.To treat below the knee first, changed to a 0.014 inch guide wire, passed through the lesion in the posterior tibial artery, expanded the balloon, and checked the blood flow below the knee.The guide wire was replaced with a thruway 0.014 and 5-6 cm of severely calcified sfa lesion was treated using the jetstream sc 1.85 mm and xc 2.4 mm.The lesion length was 2-3 cm.The lesion was pre-dilated with a 6mm diameter balloon and ranger 6x150.Slow flow was observed in the sfa on the final contrast image.A vasodilator was administered.Although the slow flow situation continued for a while, there was no problem with selective contrast imaging below the knee, so the procedure was completed.Patient had an endarterectomy of the common femoral artery (cfa) of the same toe, at which time no ulcer was found on the same toe.The ulcer subsequently progressed, leading to the present treatment.The patient was originally judged to have poor cardiac function and no lower leg below the ankle joint and was not able to tolerate bypass, so the treatment was constructed with endovascular therapy (evt).Due to the severe calcification, it was predicted that drug coated balloon (dcb) alone would not be able to treat the problem, it was decided to use jetstream.Although the influence of peripheral embolization was suggested, it was also suggested that the lack of treatment for the lower leg below the ankle joint might also be a contributing factor.Afterwards, the area below the ankle became cold, causing pain and the risk of infection, resulting in an amputation on (b)(6) 2023.The patient was stable after the amputation.

• Brand Name: JETSTREAM SC
• 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: 18083378
• MDR Text Key: 327509409
• Report Number: 2124215-2023-62197
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889861
• UDI-Public: 08714729889861
• 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: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0031980409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• 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
• Treatment: GUIDEWIRE: THRUWAY 14-300CM; INTRODUCER SHEATH: PARENT 7FR 15CM/MEDIKIT
• Patient Outcome(s): Other; Required Intervention