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

Model Number 45007

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Material Deformation (2976); Mechanical Jam (2983)

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

Event Date 04/26/2022

Event Type  malfunction  

Event Description

It was reported that there was removal difficulty.The 80% stenosed target lesion was located in a moderately calcified and moderately tortuous distal superficial femoral artery.A 2.4mm jetstream xc atherectomy catheter was selected for the atherectomy procedure.During advancement, the 45cm non-boston scientific sheath kept buckling into the aorta, making it difficult to advance the jetstream xc atherectomy catheter.The catheter ended up kinking mid shaft and was difficult to remove over the wire.Once the catheter was removed intact, rotaglide was used to wipe down the wire.A second jetstream catheter was used to complete the procedure.There were no patient complications reported.

Manufacturer Narrative

Analysis by device manufacturer: the returned product to boston scientific consisted of a jetstream xc-2.4 atherectomy catheter.The device was visually and microscopically examined for any shaft damage.Visual examination showed a kinked shaft located 65cm from the tip.A.014 test thruway wire was inserted into the device from the tip and the wire transcended through the jetstream catheter until it reached the kink where the wire stopped and would not pass the damaged area.The device was set-up and functionally tested per the ifu.The device primed and functioned as designed.The device was run for a period of 2 minutes in the blades up and down modes with no issues.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14459082
• MDR Text Key: 292196536
• Report Number: 2134265-2022-05584
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: 08714729889922
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2024
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0028815352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1