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

Model Number C3095906

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

Patient Problem Failure to Anastomose (1028)

Event Date 11/15/2022

Event Type  Injury  

Event Description

It was reported an issue with optilene suture.The client reported that on a surgery dated (b)(6) 2022 - left distal femoral-popliteal bypass with an explant.On the 8th day after surgery, the failure of the distal anastomoses due to the rupture of the thread, profuse arterial bleeding.The patient recovered without sequelae.Further information has been requested.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed in the market 2,736 units of this code batch.There are no units in stock in b.Braun surgical's warehouse.We have received 10 closed samples.We have tested the diameter of the closed samples received and the results are 0.099 mm in average, fulfilling the requirements of the european pharmacopoeia (ep): 0.070 mm < x average < 0.099 mm.We have tested the knot pull tensile strength of the closed samples received and the results fulfill the requirements of the european pharmacopoeia (ep): 0.39 kgf in average and 0.35 kgf in minimum (ep requirements: 0.15 kgf in average and 0.06 kgf in minimum).We have also tested the linear pull tensile strength of the samples received and the results are 0.58 kgf in average and 0.55 kgf in minimum.These results are the usual values for this thread and size.Please note that there are no ep/usp limits for this test.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.Remarks: as indicated in the instructions for use of the product: "when working with optilene® suture materials great care should be taken to ensure that the use of surgical instruments, such as forceps and needle holders, do not cause any crushing or crimping damage to the suture material".Final conclusion: although the results of the 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.The case is considered not confirmed by evidence of the samples received.We regret any inconvenience this issue may have caused and thank you for your collaboration.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.

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code-batch.We have received of this code-batch 5 cases from the same customer regarding the same issue at the same time.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in stock at b.Braun surgical's warehouse.We have received 54 closed samples for analysis.Tightness test to the samples received has been performed and the units are tight.Degradation test results conducted on the samples received fulfil b.Braun surgical (bbs) requirements.In the degradation test, threads are introduced in a 0.9 % nacl solution at 37ºc for 14 days.After this period, the knot pull tensile strength of the thread is tested.The results for the samples received are 2.88 kgf in average and 2.68 kgf in minimum.B.Braun surgical requirement is 1.42 kgf in minimum.These values are the usual ones for this thread and size.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.As stated in the instructions for use of the product, there are risks (side effects) associated to the use of novosyn® suture: "an existing infection may be negatively influenced by any absorbable suture.The degradation of the suture may also be slightly accelerated depending on the patient and the severity of infection.The following side effects may be associated with the use of this product: pain, granuloma, seroma, hematoma, rejection, enhanced bacterial infectivity, wound dehiscence, anastomotic leak and haemorrhage." according to the results of the tests realized to the closed samples received from the customer and the batch manufacturing record review, the product complies with our specifications; therefore, we do not see any manufacturing fault or material defect that could have caused the incidence.Final conclusion: although the results of the samples received fulfil the 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.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 CV RCP
• Type of Device: OTHER SUTURES
• 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: 17008557
• MDR Text Key: 315997619
• Report Number: 3003639970-2023-00161
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K133890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C3095906
• Device Catalogue Number: C3095906
• Device Lot Number: 122274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 78 KG