MAUDE Adverse Event Report: AESCULAP AG YASARGIL TI PERM STD-CLIP BAYO 12MM; CRANIAL IMPLANTS

Model Number FT759T

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Aneurysm (1708)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: the implant arrived in an unknown used condition and available for investigation.The implant was thermal decontaminated.The components have been examined visually and microscopically with the digital microscope and digital camera.A visual inspection of the clip was performed.A selective closed jaw was found.Also a deformed clip, the jaw was not aligned.There was visible damage and traces of usage.The device quality and manufacturing history records have been checked for the lot number and fund 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.

Event Description

It was reported by the healthcare professional to the company sales representative "jaw opened post operatively in patient.Patient had to wheel back to ot because rupture was not sealed.And another clip had to be inserted while the defected one was removed."initial clipping was done during an intraoperatively rupture, where the clip was placed rather inadvertently and not on the aneurysm.During the re-surgery (second operation), which was approximately 1 month later, the clip was retrieved and found to be in that condition, despite not being on any vessel." on (b)(6) 2017: clipping was done on (b)(6) 2017 in which the faulty clip was used.Date of event (b)(6) 2017 a cta was done just days before the 2nd re-ruptured which noted that the clips had displaced.However, patient re-ruptured.Before a 2nd operation could be planned.All med watch submissions related to this report are: 9610612-2018-00384 (this report), 9610612-2018-00394, 9610612-2018-00395, 9610612-2018-00404.

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We made a visual inspection of the clip.Here we found a selectively close jaw with an open jaw tip and jaw ending.Additionally, we found a deformed clip.Furthermore, we found that the jaw is not aligned.Additionally, we found visible damage and traces of usage.Batch history review: the device quality and manufacturing history records have been checked for the lot number and found to be according to specification, 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 dhr files, a production error or material defect can be excluded.Due to the statement in sap of the complaint: "the initial clipping was done during an intraoperatively rupture, where the clip was placed rather inadvertently and not on the aneurysm.During the second operation, which was approximately 1 month later, the clip was retrieved and found to be in that condition, despite not being on any vessel." we assume a usage error as causal factor.The not completely closed tong bits, the misaligned jaw parts, the visible damages and deformations were caused by an improper handling.The clip has not been distributed in this condition.Due to the deviation in regards to the delivery state, there is a restriction of the functionality and the possibility of a changing of the closing force.The clip should not have been used with the described damages.There is the possibility that the visible damages on the jaw parts were caused by another instrument than the applying forceps.The factory set closing force could not be checked because the clip was not in its delivery state.No capa is necessary.

• Brand Name: YASARGIL TI PERM STD-CLIP BAYO 12MM
• Type of Device: CRANIAL IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7847482
• MDR Text Key: 119321713
• Report Number: 9610612-2018-00384
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT759T
• Device Catalogue Number: FT759T
• Device Lot Number: 52292366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Distributor Facility Aware Date: 08/07/2018
• Device Age: 19 MO
• Date Manufacturer Received: 08/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention