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

Model Number 45007

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2023

Event Type  malfunction  

Event Description

It was reported that guidewire entrapment occurred.A 2.1mm jetstream xc catheter was selected for an atherectomy procedure to treat peripheral arterial disease (pad).The catheter was placed with an unknown guidewire in combination with an atherectomy lubricant.It was observed that the device was entrapped on the guidewire.Both device and guidewire had to be removed together.There were no patient complications, and the case was completed with a different device of the same model.

Manufacturer Narrative

Supplemental information was added to b5.

Event Description

It was reported that guidewire entrapment occurred.A 2.1mm jetstream xc catheter was selected for an atherectomy procedure to treat peripheral arterial disease (pad).The catheter was placed with an unknown guidewire in combination with an atherectomy lubricant.It was observed that the device was entrapped on the guidewire.Both device and guidewire had to be removed together.There were no patient complications, and the case was completed with a different device of the same model.It was further reported that the 99% stenosed lesion had a simple curvature geometry.

• Brand Name: JETSTREAM XC
• 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: 18323176
• MDR Text Key: 330958052
• Report Number: 2124215-2023-70447
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0032433329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1