MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. OPTILENE 6/0 (0,7) 75CM 2XDR13 CV2 RCP; CARDIAC SUTURE

Model Number C3097906

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

Date rec¿d by mfr: 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., (b)(4).If additional information becomes available a follow-up report will be submitted.

Event Description

It was reported an issue with optilene suture.The client reported that during endovascular graft implantation in the abdominal aorta, during arteriography of the femoral artery without calcifications, at the second passage the needle bends.There was no patient injury and the patient outcome was normal after vascular surgery.

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in our stock.We have received one open sample that contains only an used needle (reference with double needle).We have checked this needle and we have noticed that there are marks of a needle holder or other surgical instrument in the tip area and also needle attachment area.The needle has been damaged during handling and bent in the both areas most probably due to wrong handling.Therefore, we conclude that the needle bent is caused by a wrong handling not according to the instructions for use of the product.Although closed samples are needed for testing, bending strength test has been performed to the used needle received and the result is 1,08 nxcm in minimum, fulfilling minimum current bending strength for these needles: >0.91 nxcm in minimum.As stated in the instructions for use of the product, "care should be taken to avoid damaging the needle when using the suture material.Always grasp the needle in a section 1/3 to 1/2 of the distance from the fibre attachment end to the needle point, never at the end where the fibre is attached or the needle point".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.Reviewed the complaint history record of the products manufactured with the same needle raw material batches used in the production of this code-batch, there are no previous complaints in any of them.Final conclusion: the needle of the sample received showed a damage in the tip area and needle attachment area caused by a wrong handling.However, we take note of this incidence in order to assess if new or additional actions are needed.The case is considered not confirmed by evidence of the sample received.According to the analysis of the sample received and the batch manufacturing record review, the product complies with b.Braun surgical specifications.Therefore, we do not see any manufacturing fault or material defect that could have caused the incidence.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: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: OPTILENE 6/0 (0,7) 75CM 2XDR13 CV2 RCP
• Type of Device: CARDIAC SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 11684301
• MDR Text Key: 246263662
• Report Number: 3003639970-2021-00128
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C3097906
• Device Catalogue Number: C3097906
• Device Lot Number: 120426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR