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

Model Number 45007

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2018

Event Type  malfunction  

Event Description

(b)(6) study.It was reported that the device failed to aspirate.A 2.1mm jetstream device was selected for a procedure in the right mid superficial femoral artery (sfa) to treat the lesion along with a sc 1.6 jetstream catheter.The lesion had 100% occlusion, reference vessel diameter of 5 mm, and length of 50 mm and was classified as a tasc ii b lesion.During the procedure, the 2.1mm jetstream failed to aspirate.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 0 % final residual stenosis.There were no patient complications reported.

Event Description

Jetstream china study.It was reported that the device failed to aspirate.A 2.1mm jetstream device was selected for a procedure in the right mid superficial femoral artery (sfa) to treat the lesion along with a sc 1.6 jetstream catheter.The lesion had 100% occlusion, reference vessel diameter of 5 mm, and length of 50 mm and was classified as a tasc ii b lesion.During the procedure, the 2.1mm jetstream failed to aspirate.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 0 % final residual stenosis.There were no patient complications reported.Returned product consisted of a jetstream xc-2.1 atherectomy catheter.The device was visually examined for any shaft damage and the functional testing of the device was completed.The device showed 1 kink located at 13cm from the tip.Functional analysis was done by completing the aspiration testing of the device per the test procedure.The device is tested by using a 100ml beaker of water.The devices tip is submerged in a beaker of fluid and the device is run for a period of 1 minute.The final milliliters of fluid that the beaker shows after the 1minute run time is subtracted from the starting milliliters and the final number is the total that was aspirated (100ml-94ml= 6ml).The minimum amount of fluid that is aspirated per the test procedure specification sheet is 30ml per minute and the maximum is 56ml per minute.Test results showed that this device did not perform as designed per the test procedure specification sheet withdrawing 6ml of fluid in the 1minute time frame.Inspection of the remainder of the device, revealed no damage or irregularities.Because there was no evidence of any product quality deficiencies, it was considered likely that the kink was attributable to procedural factors.The kink on the device may have contributed to the aspiration problem by constricting down on the aspiration lumen.Dissection of the catheter shaft showed that the aspiration lumen was occluded with a clot burden which contributed to the aspiration issues.Device analysis determined the condition of the returned device was consistent with the reported information.The complaint was confirmed.

Manufacturer Narrative

This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/20/2018 10:18 am ct.The report number is being corrected from: 2134265-2018-64538 to: 2134265-2018-62951.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8078298
• MDR Text Key: 127551809
• Report Number: 2134265-2018-62951
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K122916
• 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: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2019
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0021394586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Date Manufacturer Received: 12/18/2018
• Patient Sequence Number: 1
• Patient Age: 68 YR