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

Model Number	45031
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
B5 (describe event or problem) and h6 (device codes) were being updated for corrections.
Event or Problem 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
• Common Device Name: 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
• Report Number: 2124215-2022-29807
• Device Sequence Number: 20468211
• Product Code: KRA
• UDI-Device Identifier: 08714729889663
• UDI-Public: 08714729889663
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K111182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: White