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 (1829)

Event Date 07/25/2019

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).

Event Description

It was reported that distal emboli occurred.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure in the left proximal to mid superficial femoral artery (sfa).On (b)(6) 2019, the subject was enrolled into the (b)(6) study and treated on the same day.A target lesion located in the left proximal to left mid sfa had 99% stenosis, a reference vessel diameter of 4.5mm, a length of 150mm and was classified as a tasc ii b lesion.The target lesion was treated with balloon angioplasty followed by debulking using an xc 2.4/ 3.4 mm jetstream catheter, resulting in 40% residual stenosis.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 30% residual stenosis.Following this, percutaneous transluminal balloon angioplasty (pta) with a drug coated balloon (dcb) was performed resulting in 25% final stenosis.During the procedure, a non-target lesion in the target limb was also treated successfully.On (b)(6) 2019, on the same day as the index procedure, distal emboli of the target limb was noted.Aspiration and plain old balloon angioplasty were performed as treatment.The event was considered recovered / resolved and the subject was discharged two days later.

Manufacturer Narrative

A1: patient identifier: (b)(6).

Event Description

It was reported that distal emboli occurred.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure in the left proximal to mid superficial femoral artery (sfa).On (b)(6) 2019, the subject was enrolled into the j-supreme ii study and treated on the same day.A target lesion located in the left proximal to left mid sfa had 99% stenosis, a reference vessel diameter of 4.5mm, a length of 150mm and was classified as a tasc ii b lesion.The target lesion was treated with balloon angioplasty followed by debulking using an xc 2.4/ 3.4 mm jetstream catheter, resulting in 40% residual stenosis.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 30% residual stenosis.Following this, percutaneous transluminal balloon angioplasty (pta) with a drug coated balloon (dcb) was performed resulting in 25% final stenosis.During the procedure, a non-target lesion in the target limb was also treated successfully.On (b)(6) 2019, on the same day as the index procedure, distal emboli of the target limb was noted.Aspiration and plain old balloon angioplasty were performed as treatment.The event was considered recovered / resolved and the subject was discharged two days later.It was further reported on (b)(6) 2019 that distal emboli of the target limb into the left anterior tibial artery (ata) was noted.There was 99% stenosis in the left ata which was treated with a balloon, resulting in 25% residual stenosis.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8921983
• MDR Text Key: 155244404
• Report Number: 2134265-2019-10089
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: 08714729889922
• Combination Product (y/n): N
• PMA/PMN Number: K133023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2020
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0023070753
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR