MAUDE Adverse Event Report: SORIN GROUP USA, INC CALIFORNIA MEDICAL LABORATORIES INC MALLEABLE VENT CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number	VT-89416
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
Through follow-up communication with the customer, sorin group learned that the device has been discarded by the customer.It was also reported that there was no delay in the surgery.The investigation is on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device discarded by the customer.
Event or Problem Description
Sorin group received a report that the tip of the malleable vent catheter disconnected during a procedure.There was no report of patient injury.
Additional Manufacturer Narrative
A photograph of an unused malleable vent catheter was provided by the customer, showing the area of disconnection to be at the catheter to vent connection junction.Research into the reported lot number found that there was no remaining inventory available for further investigation.There have been over 110 builds of this catalog number within the past year, representing almost 20,000 units.This is the first report against this catalog number for any reason, including disconnection.Without the ability to conduct an in-depth evaluation of the product, a root cause could not be determined.To address any possible production assembly issues, a manufacturing awareness notification was issued to the appropriate workforce, alerting and sensitizing the workforce to the reported malfunction.Photo received; actual device discarded.

• Brand Name: CALIFORNIA MEDICAL LABORATORIES INC MALLEABLE VENT CATHETER
• 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: 6556902
• Report Number: 1718850-2017-00007
• Device Sequence Number: 10784026
• Product Code: DWF
• UDI-Device Identifier: 00803622106439
• UDI-Public: 00803622106439
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K981601
• 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): 07/10/2017

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: 12/31/2018
• Device Catalogue Number: VT-89416
• Device Lot Number: 1633600160
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 07/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1