MAUDE Adverse Event Report: AESCULAP AG YASARGIL TIPERM STDCLIP5.0FENRTANG 5MM; CEREBRO VASCULAR CLIPS

Model Number FT644T

Device Problem Break (1069)

Patient Problem Ruptured Aneurysm (4436)

Event Date 11/17/2020

Event Type  Injury  

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 ft652t- yasargil tiperm stdclip5.0fenfdang7.5mm.According to the complaint description, the clip broke 10 days post surgery.The clip was in a patient head and after few days it burst and the bleeding accrued again.Rimary surgery: (b)(6) 2020.Revision surgery: (b)(6) 2020.The patient was transferred to an institutional home in a nursing home situation.Serial number about used clip unknown.They don't have the box since the clip was already in the tray and after sterilization.A revision surgery was necessary.Additional information was not provided.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Concomitant medical products: ft652t - yasargil tiperm stdclip5.0fenfdang7.5mm - lot gi207, ft470t - yasargil appl.Fcps mini ti.50/180mm - lot unknown.

Manufacturer Narrative

Investigation results: visual investigation: the investigation was carried out visually and microscopically.We made a visual inspection of the products.Here we found an unopened original.Package of ft652t.We made a visual inspection of the leading product ft644t.Here we discovered unknown impurities.Furthermore we found no misalignment of the jaws.Additionally the product was send to the quality assurance of the production department for further analysis.Should the investigation reveal new evidence, leading to a different conclusion, this report will updated unsolicited.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity x probability of occurrence) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Since these clips are subject to a 100% inspection of surface, geometry and closing force, a delivery condition with poor geometry is excluded.No visible deviation could be found.The product is according to the specifications no problem was fdetected during investigation.Based upon the investigations results there is capa is not necessary.

• Brand Name: YASARGIL TIPERM STDCLIP5.0FENRTANG 5MM
• Type of Device: CEREBRO VASCULAR CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11148333
• MDR Text Key: 226078226
• Report Number: 9610612-2020-00978
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT644T
• Device Catalogue Number: FT644T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FT470T; FT652T; FT470T; FT652T
• Patient Outcome(s): Required Intervention