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

Model Number	45031
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the product was returned to boston scientific for analysis.Returned product consisted of an angiojet solent omni catheter.Inspection of the device revealed multiple shaft kinks.Functional testing failed due to an under-pressure alarm message.The microscope was used to verify a detached/separated hypotube.The complaint was confirmed for under-pressure issues related to a hypotube separation.
Event or Problem Description
Reportable based on device analysis completed on 31may2024.It was reported that fluid flow back occurred.The patient underwent aortogram with thrombectomy of the target lesion located in the superficial femoral artery.An angiojet device was used in the patient; however, during power pulse mode, blood was being sucked into the outflow bag instead of spraying the clot with lytic.It was confirmed that the console was in power pulse mode during the event.The physician was unable to use power pulse mode but was able to use the thrombectomy mode to get clot out of the body as aspiration was not lost.No patient complications were reported.However, returned device analysis revealed a detached/separated hypotube.

• Brand Name: ANGIOJET SOLENT OMNI
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19598142
• Report Number: 2124215-2024-38354
• Device Sequence Number: 3980481
• Product Code: KRA
• UDI-Device Identifier: 08714729889663
• UDI-Public: 08714729889663
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2024

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: 11/08/2024
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0031174524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2022
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 69 KG