MAUDE Adverse Event Report: AESCULAP AG VARADY VARIX EXTRACTOR W/CATCH 180MM; VEIN EXTRACTOR

Model Number FB122R

Device Problems Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that the top of an extractor broke off during a vericose vein procedure.The surgeon reported that a small metal fragment (1-2 mm) broke off from the tip of the device.The metal fragment that broke off of the instrument was not able to be retrieved from the patient's body.Attending nurse indicated that the surgeon does not feel that the patient has been seriously harmed or is at risk.

Manufacturer Narrative

Investigation: the investigation was carried out visually and microscopically.The analysis of the fracture pattern illustrated a forced fracture due to overload, most likely caused by leverage.No pores, inclusions or foreign bodies could be found on the point of rupture.Batch history review: the device quality and manufacturing history records have been checked for the available lot number.The device history file has been checked and found to be according to our specification valid at the time of production.One similar incident has been filed with products from this batch.Conclusion and root cause: based on the information available as well as a result of our investigation, the root cause of the failure is most probably related to an insufficient usage.Rationale: this kind of instrument is designed for delicate use only.It is almost certain that a mechanical overload situation led to the breakage, most likely leverage.Visual investigation indicated that the quality requirements are with in the specified tolerance range.No capa is necessary.

• Brand Name: VARADY VARIX EXTRACTOR W/CATCH 180MM
• Type of Device: VEIN EXTRACTOR
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlinggen, 78501 ; GM 78501
• MDR Report Key: 7928165
• MDR Text Key: 122447812
• Report Number: 9610612-2018-00459
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FB122R
• Device Catalogue Number: FB122R
• Device Lot Number: 4506198946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Distributor Facility Aware Date: 09/28/2017
• Device Age: 4 YR
• Date Manufacturer Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other