MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 7/0 (0,5) 75CM 2XDRC10B CV RCP; CARDIAC SUTURE

Model Number C3090516

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, (b)(4) materials, process methods or other technological characteristics are registered within the u.S.K133890.When additional information has been received a follow up report will be submitted.

Event Description

It was reported that there was breakage of the thread.The device was used for a continuous suture during an intervention of carotid endarterectomy (cea) for symptomatic carotid stenosis.Per the reporter this surgical intervention is about 2 hours in duration.It was also reported that the events of breakage of the thread in particular in arterial disease caused a surgical delay of about 30 minutes.

Manufacturer Narrative

Manufacturing evaluation - samples received: there are no samples available for analysis.There are no previous complaints of the involved code-batch.There are no units in our stock.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.We have not received any sample for analysis or more information.Without any closed sample we cannot carry out an analysis in order to make a decision.Additionally, we have conducted a review of the complaint history record and there are no other complaints received of the several products manufactured with the same thread raw material batch as the complained product.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 or more information is received in the future, we will re-open the case and analyze it.

Manufacturer Narrative

Manufacturing evaluation - samples received: 62 unopened racepacks.Analysis and results: there are no previous complaints of the involved code-batch.There are no units in our stock.We have received 62 closed samples for analysis.We have tested the knot pull tensile strength of all samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 0.21 kgf in average and 0.164 kgf in minimum (ep requirements: 0.10 kgf in average and 0.036 kgf in minimum).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.Additionally, we conducted a review of the complaint history record and there are no other complaints received of the several products manufactured with the same thread raw material batch as the complained product.Final conclusion: according to the results of the samples tested and the batch manufacturing record review, the product complies with our specifications and also fulfill usp/ep requirements.Therefore, we do not see any manufacturing fault or material defect that could have caused the incidence.

• Brand Name: OPTILENE 7/0 (0,5) 75CM 2XDRC10B CV RCP
• Type of Device: CARDIAC SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8764616
• MDR Text Key: 150157285
• Report Number: 3003639970-2019-00500
• 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,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C3090516
• Device Catalogue Number: C3090516
• Device Lot Number: 118103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other