MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. STEE EL W/B 3/0 2X60 HR26/GS65V BRK; CARDIAC SUTURE

Model Number C0992704

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

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

Event Date 10/05/2023

Event Type  malfunction  

Event Description

It was reported an issue with steelex electrode suture.The customer reported that when the electrode is removed (extracted from the body), a violation of the insulation is observed.There is no reason not to assume that some of the isolation remains in the body it occurred during the extraction of electrodes from the body 8 days after the operation.There is no patient injury.No further information received.

Manufacturer Narrative

If additional information becomes available a follow-up report will be submitted.

Manufacturer Narrative

Summary of investigation: there are no previous complaints of this code-batch.We have received two different cases of the same code-batch, from the same customer, at the same time and regarding the same issue.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in our stock.We have not received any sample for analysis, only a picture showing an open and used sample with insulation of the wire damaged.However, without any closed sample we cannot carry out an analysis in order to take a decision.As stated in the precautions of the instructions for use of the product: it is necessary to inspect the steelex® electrode set prior to use and after implantation for any visible damage of the insulation.Care shall be taken to ensure that steelex® electrode set insulation is not damaged or impaired.When working with steelex® electrode set, great care shall be taken to avoid any crushing or crimping damage of the wire by instruments such as forceps or needle holders to not damage the insulation of the wire.Batch manufacturing record: reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Conclusion root cause analysis: it has not been possible to determine the root cause as no closed samples have been received, only a picture showing the used sample.Final conclusion: in spite of receiving a picture showing a defective sample, without closed samples a suitable analysis cannot be performed, and the case is considered not confirmed.Nevertheless, we take note of this incidence and if any closed sample is received in the future, we will re-open the case and analyse it.Corrective measures: 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: STEE EL W/B 3/0 2X60 HR26/GS65V BRK
• 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: 18397410
• MDR Text Key: 331382711
• Report Number: 3003639970-2023-00436
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K030556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0992704
• Device Catalogue Number: C0992704
• Device Lot Number: 121031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• 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
• Patient Age: 15 YR
• Patient Sex: Female