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

Model Number 45031

Device Problems Display or Visual Feedback Problem (1184); Suction Problem (2170)

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

Event Date 07/22/2022

Event Type  malfunction  

Event Description

It was reported that loss of aspiration occurred.The target lesion was located in the superficial femoral artery and common iliac artery.An angiojet solent omni catheter was used for thrombectomy procedure.The catheter worked for 207 seconds of run time and was removed twice during the case to allow for intravascular ultrasound.Upon re-insertion, while in thrombectomy mode, the console displayed an error for saline not correctly infusing.The error did not resolve with troubleshooting and was therefore removed.They attempted to re-prime, but the error still occurred.The procedure was completed with another of same device.No patient complications reported.

Manufacturer Narrative

B5 (describe event or problem) and h6 (device codes) were being updated for corrections.

Event Description

It was reported that loss of aspiration occurred.The target lesion was located in the superficial femoral artery and common iliac artery.An angiojet solent omni catheter was used for thrombectomy procedure.The catheter worked for 207 seconds of run time and was removed twice during the case to allow for intravascular ultrasound.Upon re-insertion, while in thrombectomy mode, the console displayed an error for saline not correctly infusing.The error did not resolve with troubleshooting and was therefore removed.They attempted to re-prime, but the error still occurred.The procedure was completed with another of same device.No patient complications reported.It was further reported that loss of aspiration did not occur, instead the console had only displayed a check saline error and system stopped all the activity.

• Brand Name: ANGIOJET SOLENT OMNI
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15246611
• MDR Text Key: 298137843
• Report Number: 2124215-2022-29807
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729889663
• UDI-Public: 08714729889663
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2024
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0029452629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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 Sex: Male
• Patient Race: White