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

Model Number 45007

Device Problems Leak/Splash (1354); Material Deformation (2976)

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

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: the device returned to boston scientific consisted of a jetstream xc-2.1 atherectomy catheter.The device was visually examined for any shaft damage.Visual analysis showed shaft damage located 1cm and 90.5cm from the tip.The infusion line showed a burst located 98.5cm from the tip.The device was set up per the instructions for use (ifu) and the device ran as designed.There was a leak noticed at the 98.5cm 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.The complaint for material deformation, kinks, and a fluid leak were confirmed.

Event Description

It was reported that an infusion line leak occurred.A 2.1mm jetstream xc atherectomy catheter was selected for an atherectomy procedure to treat peripheral arterial disease.The superficial femoral artery had been treated successfully; however, when moving distally to the popliteal and posterior tibial trunk, a catheter leak was noticed.There were no patient complications, and an eluvia was placed in the superficial femoral artery.Plain old balloon angioplasty was used to treat the distal portion to complete the procedure.

• 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: 18672960
• MDR Text Key: 336059107
• Report Number: 2124215-2024-06538
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• 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
• Device Lot Number: 0032560564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1