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 Codes	Death (1802); Perforation of Vessels (2135)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A clinical review of the complaint events was completed by creganna medical clinician as follows; ' the information received suggest that the closure device may have played a role.This would not make sense unless the user believes the sheath for the closure device was a contributor since the perforation is described as being in the iliac not the femoral.It does sound like they were able to re sheath the valve but still not clear whether the system was withdrawn with the valve fully or partially sheathed.The clinician agrees that there is no clear device to which the perforation can be attributed.The users were working with the entire system for an hour during which time there would have been much catheter manipulation and movement of devices both longitudinally and circumferentially occurred during efforts to re sheath the valve during which the perforation likely occurred but did not become apparent until removal of the system.It likely occurred due to the various stresses placed on the vessel during this effort'.A review of the manufacturing documentation for lot# 526318 and all 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 29-jan-2020, when the complaint review was completed, there was no other complaint associated with lot number 526318, for the as reported issue.A review of the lotus device risk documentation was completed.Based on this review 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.From the information available, there is no evidence indicating that the device was not used per the directions for use/product label.While the complaint description indicates "the access vessels were small in both legs," there is no indication or additional information available on the size of the vessels and if the device was used as per the ifu.The product was not returned for review at the time of this report being completed.As the device was not available for investigation and examination, it was therefore not possible to carry out any dimensional, functional, visual or microscopic examination on the device.Based on the event description and complaint investigation review, the reported issue, patient vessel perforation and death cannot be confirmed.The analysed classification assigned for this complaint was product not returned, complaint unable to confirm.The most probable investigation conclusion code assigned to this complaint is adverse event related to procedure, defined as, 'the adverse event occurred during the procedure and the device had no influence on event'.There is no information indicating issues with stenosis, calcification or tortuosity has contributed to device failure.However, the review of the returned devices indicates the complaint incident was not device related and the information reasonably suggests the issues are a result of procedural factors.Complaint information received indicates that there were challenges in locking the valve into position and does not give clear indication on the cause of perforation during the procedure and that the adverse event occurred during the procedure with no evidence of the lotus device having any influence on events.However as it cannot be ruled that the lotus did or not contribute to the adverse events, creganna medical will err on the side of caution and is reporting this complaint to the fda as a mdr.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.Creganna medical will continue to monitor for these complaint types.
Event or Problem Description
The following complaint event description was received at creganna medical; it was reported that: pt had to have a fem fem bypass to the left iliac.Converted to surgery.Pacemaker implanted.Pre-dil performed.Event date: (b)(6) 2019.Why was the fem-fem bypass it performed? - patient had a fem fem on left leg, not sure if closure was the cause, large perforation in the iliac, when was it performed? it was performed after patient was stabilized and valve deployed.The lotus introducer was used during the procedure.The patient passed away on (b)(6).The patient's anatomy was mild to mod calcification, tortuous.Patient went into chb.It is unknown whether the patient had any prior conduction issues.The perforation occurred past introducer sheath or within sheath range/length.The perforation was in the left iliac.3 mensio details were sent to creganna.User experienced a hard time locking the valve, it took multiple tries and over an hour to lock.The reason for the difficulty locking the valve was that the user(s) could not find the twisted post and had a hard time locking but eventually did lock.There was one full re sheath done and numerous partial re-sheathing.User not sure what caused the perforation which was noticed after sheath removal- user not sure if it was the closure device.According to the physician, the patient never regained consciousness after the procedure.It could not be confirmed if that the valve or wire caused the patient death.

• 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: 9647006
• Report Number: 3004193842-2020-00002
• Device Sequence Number: 2800722
• Product Code: DYB
• UDI-Device Identifier: 05391526210116
• UDI-Public: (01)05391526210116(17)210104(10)526318
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/30/2020

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: 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: 01/02/2020
• Initial Report FDA Received Date: 01/30/2020
• 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: Death; Required Intervention