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

Model Number 45007

Device Problems Entrapment of Device (1212); Suction Problem (2170); Air/Gas in Device (4062)

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

Event Date 11/29/2022

Event Type  malfunction  

Event Description

It was reported that guidewire entrapment occurred.A jetstream xc catheter, 2.1mm was selected for an atherectomy procedure to treat peripheral arterial disease.The jetstream xc catheter was used together with a non-boston scientific filter wire and rotaglide atherectomy lubricant.However, about 1.5 minutes into insertion into the lesion, it was noticed that the device was not infusing and aspirating, and the wire was entrapped in the device.A bubble error also occurred but was resolved through troubleshooting.Rexing and pinpulling the device were attempted to resolve the entrapment issue, but the entire system ended up being removed.A new catheter and filter device were used to complete the procedure.There were no patient complications reported.

• Brand Name: JETSTREAM XC
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16014892
• MDR Text Key: 306721851
• Report Number: 2124215-2022-51505
• Device Sequence Number: 1
• Product Code: MCW
• 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
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2024
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0029386587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABBOTT BAREWIRE
• Patient Age: 93 YR
• Patient Sex: Female