MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT PROXI; CATHETER, CONTINUOUS FLUSH

Model Number	45032
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the angiojet solent proxi was returned for analysis.The product was returned to boston scientific for analysis.Returned product consisted of an angiojet solent proxi catheter.There was no damage to the device.The catheter was successfully functionally tested with no leaks or alarms present.Inspection of the returned device revealed no damage or irregularities.
Event or Problem Description
It was reported that there was a loss of aspiration.An angiojet solent proxi was selected for thrombectomy procedure for a clotted fistula.During the procedure, the angiojet solent proxi catheter stopped aspirating while removing a clot, leading to no flow into the collection bag.After removing the device and placing it in saline, it still showed no aspiration.The procedure was completed with another of the same device.No complications were reported and the patient's status was stable.

• Brand Name: ANGIOJET SOLENT PROXI
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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: 20250701
• Report Number: 2124215-2024-58412
• Device Sequence Number: 15294466
• Product Code: DXE
• UDI-Device Identifier: 08714729889595
• UDI-Public: 08714729889595
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K101406
• 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): 09/18/2024

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: 12/18/2025
• Device Model Number: 45032
• Device Catalogue Number: 45032
• Device Lot Number: 0033414229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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: 46 YR
• Patient Sex: Male
• Patient Race: White