MAUDE Adverse Event Report: B.BRAUN SURGICAL SA PREMILENE 5/0 (1) 90CM 2XHR17B CV; CARDIAC SUTURE

Model Number C2095492

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, raw 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.Associated medwatch: 3003639970-2019-00531.

Manufacturer Narrative

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 stock in b.Braun surgical's warehouse.There are no samples available for analysis.Without any closed sample we cannot carry out an analysis in order to take a decision.Reviewed the batch manufacturing record, there are no incidences related to this issue and the results during the process fulfil usp/ep and b.Braun surgical requirements.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: 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.According to the batch manufacturing record review, the possible product complies with our specifications.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 5/0 (1) 90CM 2XHR17B CV
• Type of Device: CARDIAC SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8835961
• MDR Text Key: 152484483
• Report Number: 3003639970-2019-00565
• 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: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2023
• Device Model Number: C2095492
• Device Catalogue Number: C2095492
• Device Lot Number: 118152V014
• Was Device Available for Evaluation?: No
• 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