MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. OPTILENE 3/0 (2) 90CM 2XHR26 CV RCP; CARDIAC SUTURE

Model Number C3090908

Device Problems Dull, Blunt (2407); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Manufacturer Narrative

Samples received: there are no samples available for analysis.Analysis and results: the involved batch is not known.Without closed samples and/or defective samples a proper analysis cannot be performed.As no batch number is available, the batch manufacturing record cannot be reviewed.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 fiber attachment end to the needle point, never at the end where the fiber is attached or the needle point.Final conclusion: without samples we are not in position of studying if the affected product does not fulfil the specifications.In consequence, a proper analysis cannot be done and the case is not confirmed due to lack of evidence.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyze it.Please note that when no samples are received our analysis is very limited.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.

Event Description

It was reported an issue with optilene suture.The client reported that the needle deforms and its penetrability is lost after few passages.Moreover, the needle detaches from the thread.No more information is available.

• Brand Name: OPTILENE 3/0 (2) 90CM 2XHR26 CV RCP
• Type of Device: CARDIAC SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer Contact: martina laporte ; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 11573790
• MDR Text Key: 247483658
• Report Number: 3003639970-2021-00083
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K133890
• 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: 03/26/2021

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: C3090908
• Device Catalogue Number: C3090908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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