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

Model Number 45031

Device Problems Mechanical Problem (1384); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2018

Event Type  malfunction  

Event Description

It was reported that there was a hole in the catheter.An angiojet solent omni catheter was selected for use during a thrombectomy procedure.The device primed successfully, but when attempting to use the device in the patient, a hole was noticed on the catheter and the device was not functional.It is not known what caused the hole.The catheter was removed replaced with another of the same device.No complications were reported.The patient's condition after the procedure was fine.The returned device consisted of a solent omni thrombectomy system.The pump assembly, effluent/supply line, shaft and tip were microscopically and visually inspected.Blood was present outside and inside the device and there was 200ml of blood in the attached waste bag, when received.Visual inspection revealed that there was damage to the shaft in the proximal end of the catheter.Microscopic examination revealed that there was a hole in the pebax shaft 53.1cm to 53.5cm distal of the strain relief.Functional testing was performed by placing the device in the angiojet ultra console.Functional testing consisted of running the complaint device through the full priming cycle in thrombectomy mode; however, the device leaked from the hole in the shaft.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: ANGIOJET SOLENT OMNI
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7832275
• MDR Text Key: 118752993
• Report Number: 2134265-2018-60441
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729889663
• UDI-Public: 08714729889663
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2020
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0022342809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1