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

Model Number 45007

Device Problem Unintended Movement (3026)

Patient Problems Embolism (1829); Pain (1994); Injury (2348)

Event Date 10/19/2018

Event Type  Injury  

Event Description

It was reported that the patient experienced pain and distal embolization occurred and an amputation was performed.A 2.4mm jetstream xc atherectomy catheter was selected for an atherectomy procedure in the severely calcified lesion located on a third distal of the right superficial femoral artery (sfa).A 7mm non-bsc filter wire was used.The jetstream location was around 4cm lower than the distal lesion.The filter was positioned in the most healthy part of the vessel and looked well installed prior to turning on the jetstream catheter.During atherectomy, the filter slightly moved, even though it was held by the physician.Two passes with blades down and two passes with blades up for a total time of 7.18 minutes were performed.No performance issues were noted with the jetstream device.Rex all the time and catheter moves very slowly.150ml of contrast was used.After the four passes, the patient started to have pain under the right knee.Distal emboli was noticed after.The filter contained many calcium debris.The procedure was completed with a non-bsc drug coated balloon (dcb) and other percutaneous transluminal angioplasty (pta) balloons and guidewires trying to aspirate distal debris and dilate the distal vessels.Prior case, the patient had a high chance to have a below the knee amputation.A below the knee amputation was done on (b)(6) 2018 on the patient's right leg.No other patient complications were reported.

• 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 CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8033434
• MDR Text Key: 125964794
• Report Number: 2134265-2018-62532
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2020
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0022317503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 66 YR