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

Model Number 45006

Device Problems Mechanical Problem (1384); Difficult to Advance (2920)

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

Event Date 08/09/2021

Event Type  malfunction  

Event Description

It was reported a loss of rotation occurred.A 1.6mm jetstream sc atherectomy catheter was used over a thruway guidewire in an urgent rotational atherectomy procedure.The jetstream catheter was advanced; however, when reaching a critical point of the lesion, the catheter did not advance, showing a loss of rotation, and consequently was unable to progress completely into the lesion.The physician tried multiple times without success, the results were not as expected.

Manufacturer Narrative

Device/media analysis: the jetstream sc-1.6 device was received by boston scientific for analysis.The shaft and the remainder of the device were inspected for damage.Visual examination showed multiple bends on the catheter shaft as well as buckling/kinks located 8.5cm from the tip to proximal 16.5cm.The functionality of the device was checked by setting up the product per the instructions for use (ifu).The device primed as designed.There were no issues with running the device.The device activated and was run for a period of 2 minutes with no issues or errors.Inspection of the remainder of the device revealed no other damage or irregularities.The event of blades not spinning (loss of rotation) was not confirmed.

Event Description

It was reported a loss of rotation occurred.A 1.6mm jetstream sc atherectomy catheter was used over a thruway guidewire in an urgent rotational atherectomy procedure.The jetstream catheter was advanced; however, when reaching a critical point of the lesion, the catheter did not advance, showing a loss of rotation, and consequently was unable to progress completely into the lesion.The physician tried multiple times without success, the results were not as expected.

• Brand Name: JETSTREAM SC 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; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12413080
• MDR Text Key: 269518828
• Report Number: 2134265-2021-11059
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2022
• Device Model Number: 45006
• Device Catalogue Number: 45006
• Device Lot Number: 0026262249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2020
• 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: 72 YR
• Patient Sex: Male