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

Model Number 45007

Device Problems Difficult to Remove (1528); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/31/2022

Event Type  malfunction  

Event Description

It was reported there was difficulty removing the jetstream catheter from the sheath causing a rip in the catheter.This 2.1mm jetstream xc catheter was selected for use for this atherectomy procedure.During the procedure, the jetstream catheter was difficult to remove from the terumo sheath.When removing, the jetstream catheter ripped and the sheath turned "inside out".The procedure was completed successfully without sequalae.

Event Description

It was reported there was difficulty removing the jetstream catheter from the sheath causing a rip in the catheter.This 2.1mm jetstream xc catheter was selected for use for this atherectomy procedure.During the procedure, the jetstream catheter was difficult to remove from the terumo sheath.When removing, the jetstream catheter ripped and the sheath turned "inside out".The procedure was completed successfully without sequelae.

Manufacturer Narrative

Device eval by manufacturer: the device returned to boston scientific consisted of a jetstream xc-2.1 atherectomy catheter.Visual examination revealed the baton was cut off the device prior to return, and the catheter shaft was stuck in the returned 7fr sheath.Visual and microscopic examination showed multiple areas of infusion sheath damage/buckling.The device showed a burst infusion sheath on the catheter shaft located 33cm from the tip.The device could not be tested due to the extreme damage on the shaft.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint of the device having shaft damage was confirmed likely due to user handling issues.

• 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 ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15840686
• MDR Text Key: 307560474
• Report Number: 2124215-2022-47819
• 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,Followup
• Report Date: 12/21/2022

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: 04/16/2024
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0029417715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 12/08/2022
• Supplement Dates FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1