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

Model Number 45007

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem Embolism (1829)

Event Date 08/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that distal embolization occurred.A 2.4mm jetstream xc catheter was selected for an atherectomy and angioplasty procedure to treat in-stent restenosis of the superficial femoral artery (sfa).During the procedure, the physician noted the jetstream had difficulty tracking over a non-bsc guidewire.It resulted in the jetstream becoming difficult to advance and remove.Additionally, a non-bsc filterwire became displaced from its original position.It was not clear to the physician whether this related to non-bsc guidewire movement issues.The guidewire was ultimately replaced with a thruway guidewire due to a kink.Replacement with a new wire resulted in distal embolization in the below-the-knee vessels.This left the patient with one vessel run off instead of two.The physician tried to remove the distal embolization with the jetstream but otherwise left it.It was felt that running the jetstream over the thruway wire without a filter caused the distal embolization.The case was successfully completed.At no point did the wires bind to the jetstream catheter permanently or require advanced attempts to disconnect the two.However, treatment time was reduced to avoid any more serious issues.The total run-time was 16m48s and at no point did the catheter sit in the one position for an excessive amount of time.The patient status post-procedure was reported as stable.

• 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; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8965815
• MDR Text Key: 156656269
• Report Number: 2134265-2019-10672
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0023771174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2019
• 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: ABBOTT BAREWIRE; ABBOTT NAV6 FILTERWIRE; THRUWAY GUIDEWIRE
• Patient Outcome(s): Required Intervention