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

Model Number 45007

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 11/02/2023

Event Type  malfunction  

Event Description

It was reported that the catheter shaft was cracked/leaking.A 2.1mm jetstream xc atherectomy catheter was selected for use during lower limb extremity angiogram for claudication.During the procedure, during blades down mode, the jetstream catheter began leaking from a crack on the catheter shaft outside of the pedal sheath approximately 18 inches back from the catheter tip (outside of the patient).The catheter was able to be removed intact, and the procedure was completed using another device.There were no patient complications.

Manufacturer Narrative

Device eval by manufacturer: this 2.1mm jetstream xc atherectomy catheter was returned for analysis.Visual analysis found shaft damage located 41 cm and 43 cm from the tip.The device was set-up per the instructions for use (ifu) and the device ran as designed; however, there was a leak noticed at the 43 cm location.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Device analysis determined the condition of the returned device was consistent with the reported information, thus confirming the infusion line damage reported from the field.

Event Description

It was reported that the catheter shaft was cracked/leaking.A 2.1mm jetstream xc atherectomy catheter was selected for use during lower limb extremity angiogram for claudication.During the procedure, during blades down mode, the jetstream catheter began leaking from a crack on the catheter shaft outside of the pedal sheath approximately 18 inches back from the catheter tip (outside of the patient).The catheter was able to be removed intact, and the procedure was completed using another device.There were no patient complications.

• 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: 18233997
• MDR Text Key: 329362973
• Report Number: 2124215-2023-67614
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• 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: 0031965373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: White