MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME-10-AV; NEUROVASCULAR EMBOLIZATION COIL

Model Number 7110-0619-A2

Device Problem Component Missing (2306)

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

Event Date 02/21/2024

Event Type  malfunction  

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 stated to be available for return to the manufacturer but has not yet been received for analysis.The alleged product issue could not be identified.If the device is received at a later date, an investigation will be performed and a supplemental report will be submitted.

Event Description

It was reported that an embolization coil implant was missing from its delivery pusher; the device was being advanced in the microcatheter where the implant was noticed to be missing under fluoroscopy.The coil was not present in the microcatheter or packaging hoop or sterile field.A new device was used to continue the procedure.There was no injury or intervention.It was reported that there were ¿no patient care sequelae.¿.

Event Description

It was reported that an embolization coil implant was missing from its delivery pusher; the device was being advanced in the microcatheter where the implant was noticed to be missing under fluoroscopy.The coil was not present in the microcatheter or packaging hoop or sterile field.A new device was used to continue the procedure.There was no injury or intervention.It was reported that there were ¿no patient care sequelae.¿.

Manufacturer Narrative

The reported complaint is confirmed.The investigation of the returned coil system found the implant was not attached to the pusher, which is consistent with the reported event.The implant was found separated from the pusher and stuck within the dispenser hoop upon receipt.Further inspection found the implant to be deformed.The investigation found the pusher¿s monofilament with a tensile break shape at the tip, which is consistent with the device experiencing force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the pusher damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: HYDROFRAME-10-AV
• Type of Device: NEUROVASCULAR EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18852906
• MDR Text Key: 337747061
• Report Number: 2032493-2024-00195
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777023704
• UDI-Public: (01)00816777023704(11)231025(17)280930(10)0000449976
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7110-0619-A2
• Device Lot Number: 0000449976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2023
• 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