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

Model Number	45030
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an angiojet solent dista catheter.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually examined for damage or any irregularities.The shaft showed a kink located 2cm from the tip.It was also noticed that the hypotube was broken at 2cm from the tip.There was a hole in the pebax shaft material at the 2cm location.There was blood in the returned waste bag.Functional testing was competed device preparation.The pump was inserted into the ultra drive unit console.The pump and device would not prime due to the damaged shaft.There was a leak at the hole in the pebax.The devices pressure could not be recorded due to the device would not prime.Inspection of the remainder of the device showed no damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2021.It was reported that error message and pump seal fault occurred.The target lesion was located in a distal vessel.Two angiojet solent dista catheters were used in a thrombectomy procedure.However during the procedure, both the catheters displayed check saline supply error message when switched to power pulse mode and there were bubbles noticed in the pump.The procedure was completed with another of the same device.No patient complicatons were reported.However, returned device analysis revealed a hypotube break.

• 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: 11917961
• Report Number: 2134265-2021-06946
• Device Sequence Number: 13683903
• Product Code: DXE
• UDI-Device Identifier: 08714729889731
• UDI-Public: 08714729889731
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2021

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: 05/01/2022
• Device Model Number: 45030
• Device Catalogue Number: 45030
• Device Lot Number: 0025605426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR