MAUDE Adverse Event Report: CORCYM S.R.L. MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING MRCS32

Model Number	MRCS32
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/31/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed on this event through the device tracking department.Based on the information reported on the patient implant form, a memo 3d record semirigid annuloplasty ring mrcs32 was implanted and explanted on (b)(6) 2021.The device was reportedly wasted.The manufacturer has not received any allegation of a device malfunction nor of serious injury from the site regarding this event.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Since the device was wasted, no further investigation is possible at this time.The manufacturer attempted to retrieve additional information on the event and device involved, but no further information has been provided to date.Based on the limited information available, it is not possible to establish a definitive root cause for the reported event.However, from the document review performed, no manufacturing deficiencies were identified.Should any further information be received in the future, the manufacturer will provide an update to this reporting activity as applicable.Reportedly wasted.

• Brand Name: MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING MRCS32
• Common Device Name: MEMO 3D RECHORD
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 14089214
• Report Number: 3005687633-2022-00116
• Device Sequence Number: 15059922
• Product Code: KRH
• UDI-Device Identifier: 08022057015099
• UDI-Public: (01)08022057015099(240)ICV1334(17)250204
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K071327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2022

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: 02/04/2025
• Device Model Number: MRCS32
• Device Catalogue Number: ICV1334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female