MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 6/0 (0,7) 75CM 2XDRC13 (M) RCP; CARDIAC SUTURE

Model Number C3095673

Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K133890.Investigation: analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market 828 units of this code-batch.There are no units in our stock.We have received 16 closed samples and 1 open sample with a piece of thread broken.We have checked the thread surface appearance of the closed samples received and is the correct and usual one.Sewing test on artificial skin tissue has been conducted with the closed samples received and fraying/splitting does not appear when pulling the thread through the tissue.Visual appearance is the usual one after performing this test.We have also tested the knot pull tensile strength of the closed samples received and the results fulfill the requirements of the european pharmacopoeia (ep): 0.37 kgf in average and 0.29 kgf in minimum (ep requirements: 0.15 kgf in average and 0.06 kgf in minimum).Additionally, needle attachment strength test has been conducted on the closed samples received in order to discard a faulty needle-attachment during manufacturing process, but the results fulfill the requirements of the european pharmacopoeia (ep): 0.29 kgf in average and 0.218 kgf in minimum (ep requirements: 0.17 kgf in average and 0.082 kgf in minimum).We have not found splitting on thread surface on the closed samples received before and after performing tests.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Knot pull tensile strength results before releasing the product were 0.40 kgf in average and 0.37 kgf in minimum and fulfilled ep requirements.Remarks: when working with optilene® suture material, great care should be taken to avoid any crushing or crimping damage of the monofilament by instruments such as forceps or needle holders.Final conclusion: although the results of the closed samples received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.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.No corrective/preventive actions needed.

Event Description

It was reported the thread spliced and broke very easily.The reporter indicated that during a carotid artery procedure/seam patch the thread spliced and broke very easily.The patient outcome was good.

• Brand Name: OPTILENE 6/0 (0,7) 75CM 2XDRC13 (M) RCP
• Type of Device: CARDIAC SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer (Section G): B/ BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer Contact: silvia orus ; carretera de terrassa, 121; rubi, barcelona 08191 ; SP 08191
• MDR Report Key: 9405291
• MDR Text Key: 172902290
• Report Number: 3003639970-2019-00859
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2023
• Device Model Number: C3095673
• Device Catalogue Number: C3095673
• Device Lot Number: 118514V007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2018
• 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