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

Model Number FT250T

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation- the product arrived in a decontaminated condition and was available for investigation.The jaw was visibly open.We found different labeling between the primary and secondary sterile packaging.We also detected an opened jaw.Additionally, we discovered traces of usage, grooves and quirks.Furthermore we found unknown deposits.Batch history review - the device quality and manufacturing history records have been checked for the lot and found to be according to the specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause - the root cause of the problem is most probably usage related.Rationale - according to the quality standard and the manufacturing files 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 opened jaw, quirks and grooves were caused by an improper handling.There is the possibility for an incorrect gripping with the applying forceps and was thus opened too wide when opening with the forceps, or were caused by using an applier forceps from other manufacturers.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 longer in its delivery state.The clip had not been distributed in this condition.The clips should not have been used with the described damages and failures.We assume that the secondary sterile packaging comes from another used clip.Furthermore, according to the instructions for use (ifu) the following points and cautions must be observed: damage to the clip due to incorrect handling can cause restriction of the functionality and changing of the closing force.Only remove and apply with the appropriate aesculap applying clips for aneurysm clips.Discard clips that appear changed or show signs of damage (e.G.Incorrect position of the jaws, bent parts, or a changed closing force or discolorations).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 damaged products.Carefully grip using the aesculap applying forceps for aneurysm clips and remove - ensure that the clip is not incorrectly gripped.Do not use damaged clips.To avoid damage to the aneurysm clips, always treat the clip with appropriate care.

Event Description

It was reported that there was an issue with the yasargil clip.During an unspecified procedure, it was noted that the clip did not close properly.When viewing under the microscope, the clip could not be closed tightly and was not implanted.It was removed from the field and replaced with another device.The operation was continued and there was no patient injury.Additional information was not available.

• Brand Name: YASARGIL TI TEMP STD-CLIP STR 9MM
• Type of Device: CEREBRO VASCULAR CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 8537920
• MDR Text Key: 144971783
• Report Number: 9610612-2019-00272
• Device Sequence Number: 1
• Product Code: HCH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K970050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT250T
• Device Catalogue Number: FT250T
• Device Lot Number: 52466844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/12/2019
• Date Manufacturer Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2017
• 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