MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 3/0 (2) 90CM 2XHRC26(M)RCP; CARDIAC SUTURE

Model Number C3095637

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Samples received: there are no samples available for analysis.Analysis and results: there is one previous complaint of this code-batch 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.Without any closed sample we cannot carry out an analysis in order to take a decision.Nevertheless, we tested the knot pull tensile strength of the samples received in the previous complaint and the results fulfilled the requirements of the european pharmacopoeia (ep): 1.95 kgf in average and 1.74 kgf in minimum (ep requirements: 0.92 kgf in average and 0.31 kgf in minimum).A review of the batch manufacturing record for this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.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.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.

Event Description

It was reported the thread broke very easy.The reporter indicated that during an intraoperative anastomosis suturing of the aorta the suture thread broke very easily.There was no patient harm and everything was good.No other information has been provided.

• Brand Name: OPTILENE 3/0 (2) 90CM 2XHRC26(M)RCP
• Type of Device: CARDIAC SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer (Section G): B/ BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer Contact: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034 ; 8002581946
• MDR Report Key: 8604103
• MDR Text Key: 144840398
• Report Number: 3003639970-2019-00401
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: SEE H10
• 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: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2023
• Device Model Number: C3095637
• Device Catalogue Number: C3095637
• Device Lot Number: 118261V004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/01/2019
• Device Age: 9 MO
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2018
• 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