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

Model Number 45007

Device Problem Unexpected Shutdown (4019)

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

Event Date 04/27/2022

Event Type  malfunction  

Manufacturer Narrative

Device eval by manufacturer: returned product consisted of a jetstream xc-2.4 atherectomy catheter.The device was visually examined for any shaft damage and the functional testing of the device was completed.The device showed damage in the form of buckling/kinks locate 8cm from the tip to proximal 13cm.Functional analysis was performed and revealed that the rotation of the device functioned as designed.Aspiration testing was performed using a 100ml beaker of water.The devices tip is submerged in a beaker of fluid and the device is run for a period of 1 minute.Test results showed that this device did not perform as designed per the test procedure specification sheet withdrawing 0ml of fluid in the 1 minute time frame.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was not confirmed for rotational issues; however, evacuation failure was confirmed.

Event Description

Reportable based on analysis completed on 02jun2022.It was reported that this device stopped operation during treatment a jetstream xc 2.4mm atherectomy catheter was selected for use.The target lesion was located in the superficial femoral artery (sfa) and the plaque was observed to be very soft and fresh.During treatment of the lesion, the device stopped rotating and working.The procedure was able to be completed successfully using another jetstream without sequela.However, device analysis revealed the device lost aspiration.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14802926
• MDR Text Key: 296182964
• Report Number: 2134265-2022-06643
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2024
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0028994161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2022
• 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
• Patient Age: 48 YR