MAUDE Adverse Event Report: AESCULAP AG AVM MICROCLIP PHYNOX CVD.4MM STERILE; CEREBRO VASCULAR CLIPS

Model Number	FE964K
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with fe964k - avm microclip phynox cvd.4mm sterile.According to the complaint description, during an arteriovenous malformation (avm) procedure, two of the avm microclips malfunctioned.They did not "close down tight" as expected.The scrub tech loaded the clips in the applier, but two of the clips would not close after loading.It was confirmed that the applier was used to successfully secure other clips before and after the two failures.As the two micro clips were in the open position, they were easily removed from the patient without any harm or additional medical intervention.It was explained that the clips were kind of just floating in the area and not really attached to the patient's vessel.As such the devices were easily replaced with additional clips and the case was completed successfully.There was no described patient harm.Additional information was not provided.The malfunction is filed under (b)(4).
Additional Manufacturer Narrative
Based upon new information received, this event was re-evaluated and is considered no longer reportable- no malfunction or serious injury.

• Brand Name: AVM MICROCLIP PHYNOX CVD.4MM STERILE
• Common Device Name: CEREBRO VASCULAR CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11947862
• Report Number: 9610612-2021-00427
• Device Sequence Number: 13724484
• Product Code: HCH
• UDI-Device Identifier: 04046964381751
• UDI-Public: 4046964381751
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K024349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2025
• Device Model Number: FE964K
• Device Catalogue Number: FE964K
• Device Lot Number: 52624369
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLIP APPLIER; CLIP APPLIER