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

Model Number	45030
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter stuck on wire.An angiojet solent dista catheter was used for thrombectomy procedure.However, during the procedure, the catheter became stuck on wire and could not advance.The procedure was completed via alternative method or device.No patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of the solent dista thrombectomy with an unknown guidewire stuck inside the device.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.Visual examination revealed a flat spot to the shaft 64.5cm from the strain relief.Microscopic examination revealed no additional damages.Inspection of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the catheter stuck on wire.An angiojet solent dista catheter was used for thrombectomy procedure.However, during the procedure, the catheter became stuck on wire and could not advance.The procedure was completed via alternative method or device.No patient complications reported.

• Brand Name: ANGIOJET SOLENT DISTA
• 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: 15017276
• Report Number: 2124215-2022-25018
• Device Sequence Number: 20373988
• Product Code: DXE
• UDI-Device Identifier: 08714729889731
• UDI-Public: 08714729889731
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K113363
• 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,Followup
• Report Date (Section B): 08/26/2022

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: 09/30/2023
• Device Model Number: 45030
• Device Catalogue Number: 45030
• Device Lot Number: 0028535798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2021
• 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: Unknown