MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 5/0 (1) 75CM 2XDRC13 CV RCP; CARDIAC SUTURE

Model Number C3095141

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K133890.Investigation: samples received: there are no samples available for analysis.Analysis and results: there are no previous complaints of the same code-batch.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.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.Knot pull tensile strength results before releasing the product were 0.78 kgf in average and 0.74 kgf in minimum and fulfilled the requirements of the european pharmacopoeia (ep requirements: 0.31 kgf in average and 0.10 kgf in minimum).Remarks: "when working with optilene® suture material, great care should be taken to avoid any crushing or crimping damage of the monofilament by instruments such as forceps or needle holders".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.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.No corrective/preventive actions needed.

Event Description

It was reported the thread breaks very easily.The reporter indicated that during a femoral thrombendarterectomy (tea) while suturing the femoralis/artery femoralis four threads broke very easily.No patient harm and no delay in surgery.No other information has been provided.

• Brand Name: OPTILENE 5/0 (1) 75CM 2XDRC13 CV 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: 8675941
• MDR Text Key: 147325179
• Report Number: 3003639970-2019-00449
• 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: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2023
• Device Model Number: C3095141
• Device Catalogue Number: C3095141
• Device Lot Number: 118525V029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/22/2019
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2018
• 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