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

Model Number 45007

Device Problems Entrapment of Device (1212); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thromboembolism (2654)

Event Date 03/21/2024

Event Type  Injury  

Event Description

It was reported that the jetstream catheter and the wire became stuck resulting in an embolism.A 2.1mm jetstream xc atherectomy catheter and abbott barewire 315cm were selected for treatment of instent restenosis/thrombosis, total treatment was approximately 200mm (3 month old, blocked stent).The customer was instructed to go slowly advancing the jetstream catheter, treating 3cm sections at a time then using rex mode to go distal to proximal.After only one run (approximately 3.17 minutes) through with the blades down through long stent with mixed morphology, the physician was unable to remove the jetstream catheter as it was stuck with the wire.The entire system with filter and wire needed to be removed together resulting in some distal thrombo-embolization and the early cessation of the atherectomy part of the procedure.The physician used the jetstream aspiration as intervention for the embolization; however, they were not able remove all of the embolism.It was noted that there appeared to be more saline going in than what was in the waste back (volume-wise), although they did not observe a loss of aspiration and bubbles were flowing back at all times.When the device and wire were removed, the physician pulled on the wire end to try and see if it could be detached and at that point the wire unraveled.There was a big kink made in the catheter during removal of the device, but there didn't appear to be any prior to the device getting stuck on the wire.The procedure was completed using an alternate method, and the patient was expected to make a full recovery.

Manufacturer Narrative

Device eval by manufacturer: this 2.1mm jetstream xc atherectomy catheter was returned and analyzed.Visual examination revealed severe damage on the catheter shaft.Only a small piece of the abbott barewire was returned stuck in the device tip.The wire was sticking out of the tip approximately 5 cm and had been separated.The outer sheath had been stretched and pulled away from the device approximately 1.5 cm from the tip.There was a severe kink located 22 cm from the tip.The device was set up per the instructions for use (ifu) and the device primed; however, no rotation was seen due to the severe damage on the device.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.This event was confirmed for guidewire entrapment (and subsequent damage) related to the use of a non-compatible guidewire with the jetstream system.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19138900
• MDR Text Key: 340564880
• Report Number: 2124215-2024-22354
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0032820372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABBOTT BAREWIRE
• Patient Outcome(s): Other