MAUDE Adverse Event Report: SORIN GROUP USA, INC. VENTR CATH PVC 2 POS LST 18 FR; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number VT-53218

Device Problems Difficult to Remove (1528); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2015

Event Type  Other  

Manufacturer Narrative

The investigation is on going.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group received a report that the stylet was difficult to extract.There was no report of patient injury.

Manufacturer Narrative

(b)(4).Sorin group received a report that the stylet was difficult to extract.There was no report of patient injury.The involved unit was discarded, and therefore not returned for evaluation but another unit from the same lot was returned to sorin group usa for evaluation.Evaluation of the returned unit was able to reproduce the issue of difficulty removing the stylet when tested under dry conditions but once flushed, the stylet could be removed with no difficulty.The sorin vent catheter instructions for use instruct the user to "remove the stylet from the catheter and flush the catheter" prior to use.Sorin group initiated a capa in response to this issue.The capa investigation led to the conclusion that the issue was caused by a problem with the surface finish on the stylet.A review of the tubing specification revealed that the surface finish description was not specific enough to ensure the functional requirements were met.Therefore the specification was updated to call out the specific surface finish standard required and this update was communicated to the supplier of the tubing to ensure proper implementation.No further actions are deemed necessary at this time.

• Brand Name: VENTR CATH PVC 2 POS LST 18 FR
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: carrie wood ; 14401 w 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 4991193
• MDR Text Key: 22667246
• Report Number: 1718850-2015-00280
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Followup,Followup
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: VT-53218
• Device Lot Number: 1509200087
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1