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

Model Number 45031

Device Problem Entrapment of Device (1212)

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

Event Date 03/10/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) hospital.

Event Description

It was reported that the catheter was entrapped on the guidewire.The target lesion was located in the popliteal.An angiojet solent omni was used for a thrombectomy procedure.However, during the procedure, the device became entrapped on the guidewire.The procedure was completed with another of the same device.There were no patient complications reported.

Event Description

It was reported that the catheter was entrapped on the guidewire.The target lesion was located in the popliteal.An angiojet solent omni was used for a thrombectomy procedure.However, during the procedure, the device became entrapped on the guidewire.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr: the product was returned to boston scientific for analysis.Returned product consisted of an angiojet solent omni catheter.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually examined for damage or any irregularities.The catheter shaft showed multiple bends and kinks.No guidewire was received with the device.A.035 guidewire was used to verify functionality of the device per instruction for use.The guidewire was inserted into the wire lumen and passed through the tip of the device with no issues.Inspection of the remainder of the device, revealed no other damage or irregularities.The complaint was not confirmed for any guidewire issues and passed through the device.

• Brand Name: ANGIOJET SOLENT OMNI
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16674151
• MDR Text Key: 312623578
• Report Number: 2124215-2023-14122
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

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: 0029980437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2022
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 69 KG