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

Model Number	H749NTR200
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of the 18-jul-2019 when the complaint analysis was completed, the following information was received: the cause of the dissection is believed to be the lis (lotus introducer).The product was not returned for review at the time of this report being completed.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 as reported classifications of (lotus - introducer sheath - difficulty advancing) and lotus - patient - vessel dissection cannot be confirmed.Following the investigation conclusion, the compliant analysed classification is assigned as lotus - product not returned - complaint unable to confirm.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.This complaint has not been escalated to the quality management team.A review of the manufacturing documentation for lot# 526318 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 sub assembly routers did not highlight any anomalies.As of 18th july 2019, when the review was completed, there was no other complaint associated with lot number 526318, for the as reported as primary classification as lotus - introducer sheath - difficulty advancing; 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 a review of the risk documentation and information available, no updates are required to the risk documentation for the lotus introducer set device.There is no indication of a potential processing or design failure associated with this complaint.The compliant is reportable.Upon above information, the complaint has been escalated to the quality management team.The probable investigation conclusion code assigned to this complaint is 'known inherent risk of device.The definition of known inherent risk of device is: 'reported adverse event known and documented in the labelling (including both short or long term known complications or adverse reactions)'.There is no evidence of a potential processing, design or use failure associated with this complaint.Based on the above conclusion, no further escalation or corrective action is required at this time.
Event or Problem Description
Complaint description received at creganna medical is as follows: event description: per email, it was reported that: the lis sheath was inserted into the rfa initially.It would not pass through the ilio/aortic bifurcation so the physician (operator 1) removed it.No dissection was observed.A 16f edwards esheath was then inserted.The lotus 25mm valve was inserted and implanted successfully.When the esheath was removed there was evidence of a dissection.The physician ballooned it and stented it.Event date: (b)(6) 2019.

• 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: 8802386
• Report Number: 3004193842-2019-00012
• Device Sequence Number: 320739
• Product Code: DYB
• UDI-Device Identifier: 05391526210116
• UDI-Public: (01)05391526210116(17)210104(10)526318
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

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: 01/04/2021
• Device Model Number: H749NTR200
• Device Catalogue Number: LIS-L
• Device Lot Number: 526318
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/18/2019
• 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