MAUDE Adverse Event Report: SORIN GROUP USA, INC AORTIC ARCH CANNULAS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	RA-1137
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The involved device has been requested for return to sorin group usa 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 received a report that the aortic arch cannula disconnected suddenly from the tip that was inserted into the aorta during a procedure.The cannula was changed to continue the operation.The user reported significant bleeding.However, there was no additional consequence of the bleeding and no other patient injury was reported.
Additional Manufacturer Narrative
The complaint aortic arch cannula was returned to sorin group usa for evaluation.Visual inspection found that the tip was attached to the end of the cannula and would not separate, even with moderate manipulation.Leak testing was performed and the device began to leak at the connection site between the cannula tubing and the curved tip when the pressure was increased to 156 mmhg.After the leak testing the tip could be easily removed.A closer examination revealed that the cannula tip did not appear to have been bonded properly.This is a manufacturing error.The individuals responsible for assembling this cannula and cannula tip were identified based on the reported lot number.The manufacturing procedures were reviewed, the possible causes for this error were discussed and remedial training was performed to ensure that the proper steps needed for this assembly were clearly understood.The reported lot number was a build of (b)(4) devices.This is the only complaint against this lot number and this appears to be an isolated event.

• Brand Name: AORTIC ARCH CANNULAS
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC; 14401 w. 65th way; arvada CO 80004
• MDR Report Key: 6432970
• Report Number: 1718850-2017-00004
• Device Sequence Number: 10890561
• Product Code: DWF
• UDI-Device Identifier: 00803622105043
• UDI-Public: (01)00803622105043(240)RA1137(17)190831(10)1624300014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K943934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2017

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: 08/31/2019
• Device Model Number: RA-1137
• Device Lot Number: 1624300014
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 06/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR