MAUDE Adverse Event Report: AESCULAP AG YASARGIL TI PERM STD-CLIP BAYO 9MM; CEREBRO VASCULAR CLIPS

Model Number FT758T

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with product yasargil clip.During an operation the clip was placed on a neck of aneurysm.Nevertheless mild bleeding was detected afterwards.The clip was inspected.This inspection showed that the blades of the clip has not met one another.It created scissoring effect.When the clip was changed to the one made by misuho hemostasis became successful.Surgery delay was less than 15 minutes.During the operation aneurism rupture occurred.Then the aesculap clip was removed and misuho clip was placed there instead.The bleeding stopped.The operation continued in a routine mode and it was successfully finished.Patient suffered no damage from this accident and recovered successfully.There was no patient harm.Additional information was not provided nor available / was not available.This is filed under aag reference nr.(b)(4).

Manufacturer Narrative

Investigation results: the implant arrived in a clean status with heavy traces of usage and misaligned jaws.Investigation was carried out visually and microscopically.During the visual inspection of the implant we found heavy traces of usage, grooves, a quirk and misalinged jaws.The device quality and manufacturing history records have been checked for the lot number (52468027) and found to be according to the specification, valid at the time of production.No similar incidents have been filed with products from this batch.The root cause of the problem is most probably usage related.According to the quality standard and device history records a production error and a material defect can be excluded.Since these clips are subject to a 100% inspection of surface, geometry and closing force, a delivery condition with poor geometry is excluded.Investigations lead also to the assumption that the heavy traces of usage, quirk, grooves and misaligned jaws were caused by an improper handling.There is the possibility for an incorrect gripping with the applying forceps or were caused by using an applier forceps from other manufactures.Therefore there is a restriction of the functionality and the possibility of a changing of the closing force.The factory-set closing force could not be checked because the clip was no more in its delivery state.The clip has not been distributed in this condition.The clips should no more have been used with the described damages und failures.Furthermore according the instruction for use the following points and caution must be observed: (exerpt of ifu ta011251) damage to the clip due to incorrect handling, restriction of the functionality and changing of the closing force [.] prior to each use, inspect the product for: loose, bent, broken, cracked, worn or fractured components.Do not use the product if it is damaged or defective.Immediately discard any damage products.Carefully grip using the aesculap applying forceps for aneurysm clips and remove [.] do not use damaged clips [.].Check each clip individually [.].A capa was not necessary.

• Brand Name: YASARGIL TI PERM STD-CLIP BAYO 9MM
• Type of Device: CEREBRO VASCULAR CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9181867
• MDR Text Key: 176777998
• Report Number: 9610612-2019-00708
• Device Sequence Number: 1
• Product Code: HCH
• Combination Product (y/n): N
• PMA/PMN Number: K970050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT758T
• Device Catalogue Number: FT758T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1