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

Model Number 45007

Device Problems Mechanical Problem (1384); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 01/31/2022

Event Type  malfunction  

Event Description

It was reported that a separation occurred at the catheter tip.A 2.1mm jetstream xc catheter was selected to treat claudication in the superficial femoral artery and popliteal artery.The target lesion was severely calcified and 100% stenosed.Access to the lesion was obtained through the anterior tibial artery using a 7 french sheath.When the catheter was introduced into the patient, it was met with resistance causing it to kink at the mid-shaft.The catheter was removed from the patient and testing confirmed that it was functioning as intended.The catheter was reinserted using retrograde approach through the femoral artery using a 7french x 45cm destination sheath.While advancing, it was met with resistance at the popliteal artery causing the blades to stop spinning.There was difficulty removing the device so the catheter and the 0.014 thruway guidewire were removed together.Inspection of the device showed that the blade portion at the tip of the catheter had separated but not fully detached.The procedure was completed with balloon angioplasty.There were no patient complications reported.

Manufacturer Narrative

Initial reporter address 1: (b)(6).

• Brand Name: JETSTREAM XC
• 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; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13590552
• MDR Text Key: 286048064
• Report Number: 2134265-2022-01454
• 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
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2023
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0028267274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1