MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SPIROFLEX; CATHETER, EMBOLECTOMY

Model Number 10706

Device Problems Device Displays Incorrect Message (2591); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an angiojet spiroflex catheter.The pump assembly, effluent/supply line, shaft, tip and spike line were visually examined for damage or any irregularities.It was noticed when returned there was 25cc of blood in the waste bag and the device.The shaft showed multiple kinks.Functional testing was competed.The device was inserted into the test ultra drive unit console and the device was tested.The device would not prime due to the damaged shaft.There were 2 leaks along the shaft approximately 110cm and 114cm from the tip.Shaft damage at these locations in the outer shaft was noticed.The pressure was verified and was below the normal operating range.No other failures or error codes were noticed during the testing.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

Event Description

It was reported that an error message was displayed via medwatch (b)(4).An angiojet spiroflex catheter was used for a thrombectomy procedure.During the procedure, it was noted that "supply line failure" error message occurred.The catheter was re-primed and a kinked was noticed in the tubing and the saline line was unable to kept straightened.The procedure was completed with another of the same device.No patient complications were reported and patient was fine.

• Brand Name: ANGIOJET SPIROFLEX
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10871629
• MDR Text Key: 219173189
• Report Number: 2134265-2020-15961
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729889380
• UDI-Public: 08714729889380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2020

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: 02/16/2022
• Device Model Number: 10706
• Device Catalogue Number: 10706
• Device Lot Number: 0025458174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2020
• 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: 36 YR