MAUDE Adverse Event Report: B.BRAUN SURGICAL SA PREMILENE 6/0 (0.7) 60CM 2XDR12 (M)CV; CARDIAC SUTURE

Model Number C2090705

Device Problems Degraded (1153); Material Integrity Problem (2978)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/01/2019

Event Type  malfunction  

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.K980703.When additional information is provided a follow up report will be provided.

Event Description

It was reported the suture disintegrated.It was reported on (b)(6) 2019 an iliofemoral bypass operation was performed with suture material premilene 6/0 ref (b)(4), premilene 5/ref (b)(4) to fix the prosthesis.On (b)(6) 2019 the patient condition worsened and during following re-operation of endarterectomy the surgeon found disintegrated suture.Patient outcome unknown.Additional information has not been provided.

Manufacturer Narrative

Samples received: 1 unopened race pack.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 stock in b.Braun surgical's warehouse.We have received one closed sample for analysis.We have tested the knot pull tensile strength of the sample received and the result fulfils the requirements of the european pharmacopoeia (ep): 0.31 kgf (ep requirements: 0.15 kgf in average and 0.06 kgf in minimum) we have also checked the sample received before and after performing the test and no defects have been found on the thread surface.As indicated in the instructions for use of the product, when working with suture materials great care should be taken to ensure that the use of surgical instruments, such as tweezers and needle holders, does not cause the material to be damaged by being pinched or kinked.Additionally, we have conducted a review of the complaint history record and there are no other complaints received of the products manufactured with the same thread raw material batch as the complained product.Final conclusion: according to the results of the sample 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.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: PREMILENE 6/0 (0.7) 60CM 2XDR12 (M)CV
• Type of Device: CARDIAC SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8781304
• MDR Text Key: 150726551
• Report Number: 3003639970-2019-00531
• 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: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2022
• Device Model Number: C2090705
• Device Catalogue Number: C2090705
• Device Lot Number: 117492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 80