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); Leak/Splash (1354); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address (b)(6).Device evaluated by mfr.: the product was returned to boston scientific for analysis.Returned product consisted of an angiojet solent dista catheter.There was blood in the returned waste bag.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually examined for damage or any irregularities.The shaft showed multiple bends and kinks.It was also noticed that the hypotube was broken at 6cm from the tip.Functional testing was completed per device preparation.The pump was inserted into the ultra drive unit console.The pump and device would not prime due to the damaged shaft.The devices pressure could not be recorded due to the device would not prime.Inspection of the remainder of the device, apart from the observed damage showed no other damage or irregularities.The complaint was confirmed for set up issues, alarms, and errors.Shaft damage was also confirmed.
Event or Problem Description
Reportable based on device analysis completed on 14-mar-2022.It was reported that catheter failed to prime, pump assembly leaked and check saline error message occurred.An angiojet solent dista catheter was advanced for treatment.During preparation, the catheter would not complete the priming process.The physician tried to reboot the console and re-prime but still unsuccessful.A leak at the pump assembly was noticed and check saline error message occurred.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13951294
• Report Number: 2134265-2022-03372
• Device Sequence Number: 11915099
• 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
• Report Date (Section B): 03/30/2022

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: 03/23/2023
• Device Model Number: 45030
• Device Catalogue Number: 45030
• Device Lot Number: 0027436342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2021
• 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