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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 primary classification 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.A review of the manufacturing documentation for lot# 0000009192 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 (b)(6) 2020, when the review was completed, there was no other complaint associated with lot number 0000009192, for the as reported primary classification as 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 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 probable investigation conclusion code assigned to this complaint is 'known inherent risk of device' defined as 'reported adverse event known and documented in the labelling (including both short or long term known complications or adverse reactions)'.This complaint has been escalated to the quality management team.Based on the above conclusion, no further escalation or corrective action is required at this time.
Event or Problem Description
Event description: it was reported that: transfemoral access without problems with lis, inserting balloon without problems, inserting lotus edge without problems, removing lotus edge without problems, angio illiaca communis after remove lis, dissection illiaca communis right, supplying the dissection with stent, then control angio, no more dissection small video recorded was bav performed? yes associated with labeled use? yes patient status post procedure/event: fine.Event date: (b)(6) 2020.

• 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: 9706164
• Report Number: 3004193842-2020-00004
• Device Sequence Number: 3392726
• Product Code: DYB
• UDI-Device Identifier: 05391526210116
• UDI-Public: (01)05391526210116(17)210622(10)0000009192
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/13/2020

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: 06/22/2021
• Device Model Number: H749NTR200
• Device Catalogue Number: LIS-L
• Device Lot Number: 0000009192
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/13/2020
• 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