MAUDE Adverse Event Report: CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL LOTUS INTRODUCER SET; INTRODUCER CATHETER

Model Number H749NTR180

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Vascular Dissection (3160)

Event Date 10/30/2018

Event Type  Death  

Manufacturer Narrative

As of 30th november 2018, when the complaint analysis was completed, no additional information was received.If additional information is received at a later date, a follow up mdr will be filed with the fda.Based on a review of the risk documentation and information available, no updates are required to the risk documentation for the lotus introducer sheath device.There is no indication of a potential processing or design failure associated with this complaint.Based on the complaint review and the event description for this complaint, the root cause classification assigned to this complaint is 'anticipated procedural complication'.Per csop0058 rev.B, "anticipated procedural complication' is 'defined as where' utilized when a device related root cause does not apply and the complaint is due to a known physiological effect of the procedure noted within the instructions for use, and/or device labelling." vessel dissection is a procedural complication and is a known physiological effect of the procedure as noted within the instructions for use.The physician noted that the patient's abdominal aorta towards the iliac artery was tight.The complaint product was not returned to creganna medical and it was therefore not possible to carry out any dimensional, functional, visual or microscopic examination on the device.As such, the reported vessel dissection cannot be confirmed.A review of risk management documentation was completed.Based on this review and information available, it was concluded that there is no indication of a potential processing or design failure associated with this complaint and therefore no updates are required to the risk documentation due to the reported incident."eview" of the manufacturing documentation for lot# 500082 and all of its subcomponents was completed and found that the device met its material, assembly and product specifications at the time of release to distribution.The review of the router and subsequent subassembly routers did not highlight any anomalies.There were no capas (corrective and preventative action), mrrs (material review report) or deviations generated for this lot # 500082 during the manufacturing process that may have contributed to the reported issue.As of 30th november 2018, when the review was completed, there was no other complaint associated with lot number #500082, for the as reported failures lotus - patient - death and lotus - patient - vessel dissection.From the information available, there is no evidence present to indicate that the device was not used per the directions for use/product label.Following completion of creganna medical information review, the complaint analysed classification has been assigned as: "lotus - product not returned - complaint unable to confirm".Vessel dissection is anticipated procedural complication and are known physiological effect of the procedure as noted within the device instructions for use.This complaint was escalated to the quality management team.Based on the above conclusion.No further escalation or corrective action is required at this time.We will continue to monitor for these complaint types.

Event Description

Complaint description received at creganna medical is as follows: "there were no incidents with the rise and deployment of the acurate neo tavi.It was 'adecuately' positioned with a mild leak.Until then, the 'physicians was' satisfied with the procedure.When the lotus introducer was being removed, the second operator (physician) felt that the passing through the abdominal aorta towards the iliac artery was tight and with greater pressure he pulled the introducer.The blood increased inside the access, producing a hemorrhage.It was controlled, but blood pressure remained low.When performing an eco, they view a lot of blood collection at the height of the abdominal aorta.There is no more information from that moment.Vascular surgery team entered into cath lab, but it was not possible to repair the dissection.The patient died.".

• Brand Name: LOTUS INTRODUCER SET
• Type of Device: INTRODUCER CATHETER
• Manufacturer (Section D): CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL; parkmore west; galway, H91 V N2T; EI H91 VN2T
• Manufacturer (Section G): CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL; parkmore west; galway, H91 V N2T; EI H91 VN2T
• Manufacturer Contact: olivia odhiambo ; parkmore west; galway, H91 V-N2T ; EI H91 VN2T
• MDR Report Key: 8120710
• MDR Text Key: 128954377
• Report Number: 3004193842-2018-00012
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05391526210109
• UDI-Public: (01)05391526210109(17)200602(10)500082
• Combination Product (y/n): N
• PMA/PMN Number: K140338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2020
• Device Model Number: H749NTR180
• Device Catalogue Number: LIS-S
• Device Lot Number: 500082
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death