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

Model Number 100510HFRM-V-A2

Device Problems Detachment of Device or Device Component (2907); Premature Separation (4045)

Patient Problem Nerve Damage (1979)

Event Date 02/13/2023

Event Type  Injury  

Event Description

It was reported during treatment of cavernous fistula, flushed coil and multiple catheters.Fairly tortuous anatomy.Coil did feel less smooth than normal but not overly noticeable at the time.About 2cm of coil was deployed out of the catheter when the physician decided to resheath and reposition the loops.The coil would not resheath.The coil could also not be pushed out any further.After several attempts without success, the pusher wire was retracted but found to be without coil.The physician then tried to pull the microcatheter into the guiding catheter.Eventually the catheter/coil devices had to be pulled out.There was a reported 3 hour delay in the procedure as noted to be a result from having to take all products out to retrieve coil.It took time to reaccess.Had to cut benchmark catheter just outside the sheath as the coil was stuck inside the benchmark.It is noted the patient has a permanent 6th nerve palsy 95%.The physician reported that it was probably unrelated to the coil and most likely related to the onyx.

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 for evaluation but has not yet been returned.The coil detachment and event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.

Event Description

No additional information was obtained.See h10.

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 visual analysis of the returned items found the microcatheter returned cut.A pair of surgical scissors with a portion of stretched thick, flat coils were also returned for evaluation.The thick, flat coils and thin coils which were stretched out and located between the severed parts of the microcatheter were part of the microcatheter itself.After a thorough investigation, no evidence of the coil system being stuck inside the returned catheter was found; furthermore, the coil system in question - complained against, was not returned for evaluation.Without the device being returned and evaluated, the investigation could not test or assess the alleged product issue.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated¿with the use of the device.

• Brand Name: HYDROFRAME-10-AV
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• 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: 16517141
• MDR Text Key: 311037133
• Report Number: 2032493-2023-00604
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777023520
• UDI-Public: (01)00816777023520(11)221025(17)270930(10)0000278402
• 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: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100510HFRM-V-A2
• Device Lot Number: 0000278402
• 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: 04/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female