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 Code	Thrombus (2101)
Date of Event	03/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported compliant device has not been returned to creganna medical to date, therefore a technical analysis could not be completed.Should the device be received at creganna medical in the future, the investigation report will be updated and a supplemental mdr containing the updated information will be filed with the fda.A review of the manufacturing documentation for the reported lot# 426577 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.A similar complaint review was completed for lot# 426577 to determine if other complaints had been reported against this lot with a similar failure mode.No other device complaints from this lot were reported with the same reported failure mode.A ship history was not required to be performed at this time as the batch number of the complaint device is known.Based on a review of the risk documentation and information available, no updates are required to the risk documentation for the lotus device.There is no indication of a potential processing or design failure associated with this complaint.Thrombosis is considered as an anticipated procedural complication as noted within the instructions for use.From the information available, there is no evidence to indicate that the device was not used per the directions for use/product label.The root cause classification assigned to this complaint is 'anticipated procedural complication.' the definition of anticipated procedural complication is 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.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
Initial complaint description was received at creganna medical on 12-mar-2018 as follows: 'problem during the insertion of the transglide introducer sheath (b)(4) because the dilator didn't advance in the mesh so a second attempt with lis-s (426577) was successfully completed.At this point the procedure was successfully completed but after the introducer removal a thrombus was noticed at level of external iliac that was removed surgically.' additional information was on the complaint notification form as follows; 'indication of procedure :aortic valve stenosis.Was ivus used? no.Was a generator involved? no.Was the problem associated with labeled use? yes.Action taken by the physician to try to resolve the event: surgery: vascular surgery intervention to remove the thrombus.Event resolved? yes.Physician assessment of the relationship of the event to the device: related.Please check all those that can be forwarded to bsc: procedure notes.'.

• 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: 7406093
• Report Number: 3004193842-2018-00003
• Device Sequence Number: 173457
• Product Code: DYB
• UDI-Device Identifier: 05391526210109
• UDI-Public: (01)05391526210109(17)190918(10)426577
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K140338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2018

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: 09/18/2019
• Device Model Number: H749NTR180
• Device Catalogue Number: LIS-S
• Device Lot Number: 426577
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 04/09/2018
• 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