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

Model Number 45007

Device Problems Mechanical Problem (1384); Difficult or Delayed Activation (2577); Air/Gas in Device (4062)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the jetstream catheter had error codes and blades would not activate.This 2.4 mm jetstream xc atherectomy catheter was selected for this atherectomy procedure.The catheter was prepared and inserted into the patient; however, when activated there was a bubl error that appeared.The catheter was purged a second time and inserted again into the patient, but another error for grd2 appeared even though the guidewire was well seated in the gard and the blades up/down would not activate.The procedure unable to be completed post-sedation with general anesthesia.There were no patient complications.

Manufacturer Narrative

E1: initial reporter address: (b)(6).E1: initial reporter phone: (b)(6).Device evaluation by manufacturer: this 2.4 mm jetstream xc atherectomy catheter was returned and analyzed.Visual and microscopic examination revealed no shaft damage.The device was set-up and functionally tested per the instructions for use (ifu).The device was connected to the test console and the device primed as expected.A.014 guidewire was inserted into the gard and the device was activated; however, no rotation was observed, and the console showed a gard error.The wire was manipulated in the gard to see if it would make better contact and the gard component was also exchanged for new gard, yet the error persisted.An x-ray of the gard wire revealed a broken wire inside the blue molded wiring junction.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The bubl error was not able to be replicated; however, a gard error and activation issues experienced in the field were confirmed through analysis.

Event Description

It was reported that the jetstream catheter had error codes and blades would not activate.This 2.4 mm jetstream xc atherectomy catheter was selected for this atherectomy procedure.The catheter was prepared and inserted into the patient; however, when activated there was a bubl error that appeared.The catheter was purged a second time and inserted again into the patient, but another error for grd2 appeared even though the guidewire was well seated in the gard and the blades up/down would not activate.The procedure unable to be completed post-sedation with general anesthesia.There were no patient complications.

• 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 CORK LIMITED
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18808382
• MDR Text Key: 336616886
• Report Number: 2124215-2024-11869
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: CS
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Race: White