MAUDE Adverse Event Report: MICROVENTION, INC WEB SL 21 SINGLE LAYER; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number W4-6-4-CN

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 09/18/2023

Event Type  malfunction  

Event Description

As reported, the right bifurcation of the brain was planned.When flushing device, the physician found small particles inside the sphere of the web.For safety reasons, it was replaced with w4-6-3.There was no patient involvement.Procedure completed with alternate, and the patient is reported to be fine.

Manufacturer Narrative

A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

• Brand Name: WEB SL 21 SINGLE LAYER
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18049566
• MDR Text Key: 327093429
• Report Number: 2032493-2023-01022
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429113776
• UDI-Public: (01)00842429113776(11)211209(17)251130(10)0000132519
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W4-6-4-CN
• Device Lot Number: 0000132519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 50 KG