MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 6/0 (0,7) 75CM 2XDRC13B CV RCP; CARDIAC SUTURE

Model Number C3095836

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

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

Event Type  Injury  

Manufacturer Narrative

Pma/510k: 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.When additional information becomes available a follow up report will be submitted.

Event Description

It was reported that the needle detached.The reporter indicated that during coronary artery bypass grafting (cabg) of the proximal anastomosis, after the surgeon stitched (using continuous suture technique) on one arm of the needle of the coronary artery, he then wanted to start stitching using the other arm, he found that the needle was missing.The surgeon and nurses spent 3 hours searching, however, couldn't find the dislodged needle.The patient was put under c-arm fluoroscopy but couldn't detect the needle.The nurse then put one of the black needles of c3095836 under the c-arm fluoroscopy and found that it couldn't be detected.Per the reporter the patient outcome was well and no patient injury.However, no patient injury per the reporter, this patient did require a 3 hour search for the missing needle and medical intervention of the c-arm fluoroscopy to also search for the missing needle.The needle was not located.

Manufacturer Narrative

Investigation: three possible batches involved in the incident: 118101, 117147 and 117112.In this case, we cannot be absolutely sure then that the complaint sample is indeed from batch 118101.It may be from the other batches as well and we have no way of knowing, as the hospital as well did not take note which batch was used.Samples received: two closed samples of batch 117112 and a closed sample of batch 117147.No samples of batch 118101.Analysis and results: there are three possible batches involved: 118101, 117147 or 117112.There are no previous complaints of any of the three possible code batches.We manufactured and distributed (b)(4) units of batches 117112 and 117147, and we manufactured and distributed (b)(4) units of batch 118101.There are no units in our stock.We have received two closed samples of batch 117112 and a closed sample of batch 117147.We have not received any sample of the batch 118101 for analysis.We have tested the needle attachment strength of the closed samples received and the results fulfill the requirements of the european pharmacopoeia (ep): 0.37 kgf in average and 0.254 kgf in minimum (ep requirements: 0.17 kgf in average and 0.082 kgf in minimum).Reviewed the batch manufacturing records, these products had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.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.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.

• Brand Name: OPTILENE 6/0 (0,7) 75CM 2XDRC13B 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: 8862244
• MDR Text Key: 172023468
• Report Number: 3003639970-2019-00587
• 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
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C3095836
• Device Catalogue Number: C3095836
• Device Lot Number: 118101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Date Manufacturer Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 65