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

Model Number 45007

Device Problem Mechanical Problem (1384)

Patient Problems Embolism (1829); Hemorrhage/Bleeding (1888); Pseudoaneurysm (2605)

Event Date 08/21/2020

Event Type  Injury  

Event Description

It was reported that embolism, hemorrhage and pseudoaneurysm occurred. A contralateral approach was used to access the 70-80% stenosed target lesion located in the moderately calcified left superficial femoral artery (sfa) and popliteal artery. A non-bsc wire and catheter was used to cross the lesion successfully. The wire was exchanged to a 0. 014 inch thruway wire. The wire was exchanged again for a non-bsc embolic protection system. Then a 2. 1mm jetstream xc atherectomy catheter was prepared for use. The device primed properly and was inserted into the patient. Atherectomy was initiated and the jetstream was passed slowly through the lesion and pulled back via rex mode. A second passage was made with blades down. During the third pass with blades up, the device became momentarily caught in the lesion though did cause any problems. The device was pulled back a bit and then atherectomy was further performed in blades up mode. The device was pulled back out of the lesion using rex mode. Post-dilation was performed successfully with two ranger balloons, 4mm and 5mm diameter. There was little blood flow when the lesion was checked and it was suspected that the non-bsc embolic protection system may have been the cause so it was removed. The minimal blood flow persisted and embolism was observed. A non-bsc catheter and non-bsc separator were used to perform a thrombectomy. It was noted that the mid-sfa was bumpy at the location where the jetstream had become momentarily caught. Hemorrhage and pseudoaneurysm in the mid-sfa were observed and a non-bsc stent graft was placed to remedy this. The physician's opinion was that the jetstream or the non-bsc thrombectomy device caused the hemorrhage and pseudoaneurysm. The lower leg tibial vessels were dilated to treat stenosis. No further patient complications were reported and patient was reported as stable post procedure.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10505737
• MDR Text Key: 206098168
• Report Number: 2134265-2020-12190
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0025686868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/08/2020 Patient Sequence Number: 1

Treatment

MEDTRONIC SPIDER EMBOLIC PROTECTION SYSTEM; PENUMBRA CAT6 CATHETER; PENUMBRA SEPARATOR; RANGER BALLOON 4MM; RANGER BALLOON 5MM; THRUWAY .014 GUIDEWIRE