MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 7/0 (0,5) 60CM 2XDR8 CV RCP; CARDIAC SUTURE

Model Number C3090888

Device Problem Material Integrity Problem (2978)

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

Event Date 10/22/2019

Event Type  malfunction  

Manufacturer Narrative

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 optilene.During an unspecified procedure, the threads were noted to be fibrous and break after several stitches.It was likely a pediatric cardiac surgery.There was no patient harm.

Manufacturer Narrative

Analysis and results: there are no previous complaints of the same code-batch.We manufactured and distributed in the market 900 units of this code-batch.There are no units in our stock.We have received 10 closed samples and 1 open sample that shows fraying/splitting in the thread surface.We have tested the knot pull tensile strength of the closed samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 0.21 kgf in average and 0.192 kgf in minimum (ep requirements: 0.10 kgf in average and 0.036 kgf in minimum).Sewing test on artificial skin tissue has also been conducted with the closed samples received and fraying/splitting does not appear when pulling the thread through the tissue.Visual appearance of the thread is the usual one.Nevertheless, taking into account the open and used sample received shows fraying/splitting, we consider that the complaint is confirmed by evidence of the failure in the open sample received.Reviewed the batch manufacturing record of this product, there was an incidence but was released into the market fulfilling usp/ep and b.Braun surgical requirements.Final conclusion: we conclude that the complaint is confirmed by evidence of the failure in the open sample received.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.Corrective/preventive actions: this complaint is recorded for trending analysis to assess if actions are needed.

• Brand Name: OPTILENE 7/0 (0,5) 60CM 2XDR8 CV RCP
• Type of Device: CARDIAC SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9298837
• MDR Text Key: 167571803
• Report Number: 3003639970-2019-00783
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: K133890
• 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: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C3090888
• Device Catalogue Number: C3090888
• Device Lot Number: 118384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1