MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL ARTERIAL CAN.22FR FLANGE WLL; PUREFLEX ARTERIAL CANNULAE

Model Number	RA22-2BB BENT FLANGE TIP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information were not provided.Sorin group italia manufactures the pureflex® arterial cannula ra22-2bb bent flange tip.The incident occurred in poland.The involved cannula is not available for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Sorin group italia has received a report that, at the end of a procedure, the body of the cannula was severely damaged.There is no report of any patient injury.According to the surgeon they used the same clamps as usual.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
The dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.An exhaustive photo was provided as evidence of the defect, showing a failure of the cannula body material near the clamping area.The complaints' review performed was able to identify no other similar issue on the product part number ra2x-xxx in the 3 years.Thus, the event is isolated.Considering that the lot involved was (b)(4) units distributed worldwide, and no other similar event was recorded either on the affected lot or on the affected code in the last three years, a manufacturing failure of the cannula can be resonably ruled out.However, considering that the defect occurred at the end of the procedure, it cannot be excluded that the material deteriorated progressively during use most likely because of inadvertidely initial rough handling of user.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: ARTERIAL CAN.22FR FLANGE WLL
• Common Device Name: PUREFLEX ARTERIAL CANNULAE
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola
• Manufacturer (Section G): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 15985132
• Report Number: 9680841-2022-00060
• Device Sequence Number: 14974724
• Product Code: DWF
• UDI-Device Identifier: 08033178017053
• UDI-Public: (01)08033178017053(17)250920(10)2209210105(11)220921(240)RA22-2BB
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2025
• Device Model Number: RA22-2BB BENT FLANGE TIP
• Device Catalogue Number: RA22-2BB
• Device Lot Number: 2209210105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2022
• 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
• Patient Sex: Unknown