MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL AORTIC ARCH CANNULAE, OPTIFLOW AORTIC ARCH CANNULA; CATETHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	A282-70A
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information were not provided.Date of event is unknown.Sorin group (b)(4) manufactures the optiflow aortic arch cannula.The incident occurred in (b)(6).The involved device has been requested for return to sorin group (b)(4) for investigation and it is not yet received.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not yet returned.
Event or Problem Description
Sorin group (b)(4) has received a report that, upon cannulation, the tip of the aortic arch cannula detached.There is not report of any patient injury.
Additional Manufacturer Narrative
H.10: the complained device a282-70a optiflow cannula returned to livanova facility for investigation.Visual inspection of the cannula found the tip broken and detached from cannula body.No blood residue was found in the returned cannula suggesting the cannula has not been used.In addition, another broken and detached tip of the same type of cannula was returned to livanova.Follow up with the customer clarified that, differently from what initially stated, the cannula tip fractured when being inspected by the surgeon prior to insertion.In addition to the above, livanova has been informed that on the same occasion, during visual inspection upon usage, a second similar cannula fractured.The customer elected to return all similar unused cannula in stock.The condition of the unused returned cannula made impossible to perform any investigation: the outer shipper was severely damaged.Review of the manufacturing record did not identify any issue: the cannulas were released according to product specifications.No other similar complaint was submitted relevant to the claimed batch.Livanova investigation could not identify any root cause of the event.Based on the conditions of returned device and as per collected evidences, the reported material breakage has been reasonably traced back to mechanical hit/compressive stresses accidentally applied to cardboard boxes after product release during handling/transportation phases, exceeding what the packaging has been developed to sustain.No specific device-related malfunction could be identified.As this appears as any isolated case and no specific root cause could be identified, no corrective action will be undertaken.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: AORTIC ARCH CANNULAE, OPTIFLOW AORTIC ARCH CANNULA
• Common Device Name: CATETHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 9568216
• Report Number: 9680841-2020-00003
• Device Sequence Number: 438897
• Product Code: DWF
• UDI-Device Identifier: 08033178004961
• UDI-Public: (01)08033178004961(17)221110(10)1911110040
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K162215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

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: 11/10/2022
• Device Model Number: A282-70A
• Device Catalogue Number: A282-70A
• Device Lot Number: 1911110040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1