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-53218
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The device was switched out to continue the procedure.There was no report of patient injury.
Additional Manufacturer Narrative
The involved vent catheter was discarded by the customer and could not be returned for evaluation.No photographs of the device were taken.The customer provided two lot numbers but was not sure which one might have been involved.Research was unable to identify any remaining inventory for either lot number.A production review found that there have been over 160 builds of this catalog number within the past year, representing almost 80,000 units.This is the first complaint for the two parts of the catheter separating.Without product for an in-depth evaluation of this incident, the root cause and appropriate corrective action could not be determined.To address any possible production assembly issues, a manufacturing awareness notification was issued to the appropriate workforce, alerting them to the complaint and sensitizing them to the reported issue.

• 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: 6563097
• Report Number: 1718850-2017-00008
• Device Sequence Number: 865230
• Product Code: DWF
• UDI-Device Identifier: 00803622106347
• UDI-Public: 00803622106347
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 07/06/2017

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 Catalogue Number: VT-53218
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2017
• Supplement Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1