MAUDE Adverse Event Report: COOK INC NOVAPASS REVERDIN SUTURE PASSER; GEJ CARRIER, LIGATURE

Catalog Number C-PAS-30-11.4

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient code: blood loss selected for "bleeding" is not labeled; no code available selected for "required intervention".Device code: no known device issues reported.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that the device was used for trans-facial sutures with superior and inferior midline fixation points and 3 lateral fixation points.No perioperative bleeding was noted was reported.However, the patient had to returned to theatre post operatively to control bleeding into the rectus muscle.The surgeon believes the bleeding was due to using the reverdin novapass for the transfascial sutures.Questions were asked about the patient and the event.At this time, no further details regarding the patient or event have been provided.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, documentation, instructions for use (ifu), and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.The device is shipped with instruction for use (ifu) which notes: "exercise extreme caution during use of this device to avoid unintentional puncture/perforation of vessel, never, bowel, or any other internal organs or vital anatomical structures.¿ also, ¿do not use suture passer in a procedure where the position of the needle tip cannot be clearly identified.¿ clinical assessment cannot eliminate any possible causes for this event such as product handling, medical procedure, patient physiology, device failure, or manufacturing related causes.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

Event Description

No additional information has been reported since the submission of the initial report on 5/15/2018.

• Brand Name: NOVAPASS REVERDIN SUTURE PASSER
• Type of Device: GEJ CARRIER, LIGATURE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7516450
• MDR Text Key: 108352163
• Report Number: 1820334-2018-01469
• Device Sequence Number: 1
• Product Code: GEJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-PAS-30-11.4
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention