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

Model Number 45007

Device Problem Material Deformation (2976)

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

Event Date 12/08/2022

Event Type  malfunction  

Event Description

It was reported that the infusion line ruptured.The jetstream xc atherectomy 2.1mm catheter was selected for treatment of superficial femoral artery occlusion.The physician noted difficulty passing the catheter through the cook flexor sheath.The catheter was operated for two passes, however, when they switched to blades up mode, they observed two large fragments of plastic wrapped around the jetstream catheter.The infusion line had ruptured.The jetstream was stopped due to risk of plastic entering the patient, and the procedure continued using balloon catheters and stents.The finished outcome was successful.No reported patient complications.

Event Description

It was reported that the infusion line ruptured.The jetstream xc atherectomy 2.1mm catheter was selected for treatment of superficial femoral artery occlusion.The physician noted difficulty passing the catheter through the cook flexor sheath.The catheter was operated for two passes, however, when they switched to blades up mode, they observed two large fragments of plastic wrapped around the jetstream catheter.The infusion line had ruptured.The jetstream was stopped due to risk of plastic entering the patient, and the procedure continued using balloon catheters and stents.The finished outcome was successful.No reported patient complications.

Manufacturer Narrative

Device eval by manufacturer: the device returned to boston scientific consisted of a jetstream xc-2.1 atherectomy catheter.Visual and microscopic examination showed a kink on the catheter shaft located 53cm from the tip.The catheter shaft also showed multiple bends.Further examination revealed a burst infusion sheath on the catheter shaft located 68cm to 70cm from the tip.The device was inserted into the console and set up per the instructions for use (ifu).The device ran as designed; however, the device leaked fluid during functional testing at the burst infusion sheath location.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Device analysis confirmed the allegation of material separation reported from the field.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• 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: 16016013
• MDR Text Key: 307191331
• Report Number: 2124215-2022-52918
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2023
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0028549093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1