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

Model Number 45031

Device Problems Break (1069); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2024

Event Type  malfunction  

Event Description

It was reported that tip of the catheter was hydroped and ruptured occurred.The target lesion was located in the lower extremity vein.An angiojet solent omni was selected for use for thrombectomy procedure.During the procedure, error was reported and the tip of the balloon was hydroped and ruptured.The procedure was successfully completed with another of the same device and the patient was stable.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an angiojet solent omni catheter.Inspection of the device revealed shaft kinks.The x-ray was used to verify a hypotube perforation/hole.The complaint was confirmed for under-pressure issues related to a hypotube perforation/hole.

Event Description

It was reported that tip of the catheter was hydroped and ruptured occurred.The target lesion was located in the lower extremity vein.An angiojet solent omni was selected for use for thrombectomy procedure.During the procedure, error was reported, and the tip of the balloon was hydroped and ruptured.The procedure was successfully completed with another of the same device and the patient was stable.It was further reported that an error message occurred, pump assembly leakage was noted, and shaft rupture occurred 5cm from the hub.

• Brand Name: ANGIOJET SOLENT OMNI
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18722153
• MDR Text Key: 336419006
• Report Number: 2124215-2024-08730
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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
• Device Operator: Health Professional
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0031436745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2023
• 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
• Patient Age: 46 YR
• Patient Sex: Female