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

Model Number	H749NTR180
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Blood Loss (2597)
Date of Event	07/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for review.As the device is not available for investigation and examination, it was therefore not possible to carry out any dimensional, functional, visual or microscopic examination on the device.Therefore, the reported issue could not be confirmed.Following the 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.There were no corrective and preventative action (capa), material review report (mrr) or deviation generated for this lot# 495598 during the manufacturing process that may have contributed to the reported issue.As of 22 august 2018, when the review was completed, there was no other complaint for lot# 495598, for the reported failure mode.From the information available, there is an evidence present to indicate that the device was not used per the directions for use/product label.As per the event description for this complaint, the doctor did not flush the side port, nor did he have instant back bleed.This is contrast to the directions as per the user manual part number 139816-01.Creganna medical requested additional information to verify if the physician was trained in the use of the device.We have not received a response as of when the complaint was being closed.Should we receive this information at a later date, this complaint will be re-opened and updated accordingly if it changes the conclusions of the investigation and a follow up mdr will be filed with the fda.The most probable root cause of the reported complaint is 'user/ user error', defined as 'confirmed through compliant investigation that there was an act or omission of an act that resulted in a different medical device response that intended by the manufacturer or expected by the user'.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 or Problem Description
Complaint description received at creganna medical is as follows: "the problem occurred after insertion of the lotus sheath, the doctor did not flush the side port, nor did he have instant back bleed.The side ports sat in the drapes where pooling of blood was later found.The patient became unstable and the blood loss was discovered.Two units of blood where given.The patient recovered from this episode fully without any lasting detrimental effects.Physician assessment of the relationship of the event to the device: unrelated.My understanding of the information we have currently is the event is related to the device not getting flushed and not necessarily a malfunction of the device.Other possible contributing factors to the event: the doctor forgot to flush the side port and did not immediately observed bleeding from the side port after the lotus sheath was inserted".

• Brand Name: LOTUS INTRODUCER SET
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): CREGANNA MEDICAL ALSO D.B.A CREGANNA TACTX MEDICAL; parkmore west; galway, H91 V N2T; EI H91 VN2T
• MDR Report Key: 7811267
• Report Number: 3004193842-2018-00006
• Device Sequence Number: 11041931
• Product Code: DYB
• UDI-Device Identifier: 05391526210109
• UDI-Public: (01)05391526210109(17)200506(10)495598
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2020
• Device Model Number: H749NTR180
• Device Catalogue Number: LIS-S
• Device Lot Number: 495598
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention