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

Model Number	45030
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the product was returned to boston scientific for analysis.Returned product consisted of an angiojet solent dista catheter.He pump assembly, effluent/supply line, shaft, tip and spike line were visually examined for damage or any irregularities.The tip showed a severe showed a kink.Functional testing was competed per the device preparation.The pump was inserted into the ultra drive unit console.The pump and device would not prime.The pressure was below the normal range.Microscopic analysis showed that the joint where the tip is inserted into the nitinol was leaking fluid and pressure.The devices pressure was not within the normal range.Inspection of the remainder of the device, apart from the observed damage showed no other damage or irregularities.
Event or Problem Description
It was reported that loss of aspiration occurred.The target lesion was located in the iliac artery.An angiojet solent dista catheter was used for a thrombectomy procedure.During the procedure while in thrombectomy mode, the catheter did not suction.No patient complications reported and the patient's status was stable.

• Brand Name: ANGIOJET SOLENT DISTA
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11517463
• Report Number: 2134265-2021-03201
• Device Sequence Number: 3827764
• Product Code: DXE
• UDI-Device Identifier: 08714729889731
• UDI-Public: 08714729889731
• Combination Product (Y/N): N
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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: 12/12/2022
• Device Model Number: 45030
• Device Catalogue Number: 45030
• Device Lot Number: 0026790296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR