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

Model Number 45006

Device Problems Entrapment of Device (1212); Mechanical Problem (1384); Unintended Movement (3026); Noise, Audible (3273)

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

Event Date 10/19/2023

Event Type  malfunction  

Event Description

It was reported that the catheter was entrapped on the guidewire.A 1.85mm jetstream xc catheter and non-bsc filterwire were selected for use in an atherectomy procedure to treat a non-healing wound of the right foot.The target lesion was located in the right popliteal artery.The catheter was successfully prepped and advanced to the target lesion.Upon initial activation, the filterwire positioning in the catheter changed, instead of staying in its original position.Before engaging the lesion, the sound of the device seemed slower, and while engaging the lesion the catheter bogged down.After several attempts, the physician opted to remove the catheter.However, the catheter was entrapped on the filterwire and therefore, the catheter and filterwire had to be removed together.The procedure was completed using a balloon and cutting-balloon.The patient was stable the entire procedure and there were no complications.

Manufacturer Narrative

Device eval by mfr: the device was returned and analysis completed.Returned product consisted of a jetstream sc-1.85 a non-compatible command guidewire was returned in the device.The device and the catheter shaft were analyzed for damage.Visual examination showed severe buckling and kinks located from the tip to proximal 68cm.There was a non-compatible guidewire in the device.The wire could not be removed.The wire was sticking out of the distal end approximately 12.5cm and from the proximal end of the pod 143cm.The device was set up per the ifu and the device primed and ran as designed labored and sporadic.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was not confirmed for blades not spinning; however, guidewire sticking was confirmed due to the shaft damage and the non-compatible guidewire used.

Event Description

It was reported that the catheter was entrapped on the guidewire.A 1.85mm jetstream xc catheter and non-bsc filterwire were selected for use in an atherectomy procedure to treat a non-healing wound of the right foot.The target lesion was located in the right popliteal artery.The catheter was successfully prepped and advanced to the target lesion.Upon initial activation, the filterwire positioning in the catheter changed, instead of staying in its original position.Before engaging the lesion, the sound of the device seemed slower, and while engaging the lesion the catheter bogged down.After several attempts, the physician opted to remove the catheter.However, the catheter was entrapped on the filterwire and therefore, the catheter and filterwire had to be removed together.The procedure was completed using a balloon and cutting-balloon.The patient was stable the entire procedure and there were no complications.

• Brand Name: JETSTREAM SC
• 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: 18095379
• MDR Text Key: 328598682
• Report Number: 2124215-2023-58719
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889861
• UDI-Public: 08714729889861
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2024
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0029161162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Race: White