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

Catalog Number VT-53218

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2015

Event Type  Other  

Event Description

Sorin group received a report that while removing the stylet from the catheter, the handle and metal inner support wire came out leaving the blue outer portion in place.This was not noticed and the vent tubing was attached.During the case, the vent had to be run at a higher pump rate.No other problems occurred as a result of the stylet part in the catheter.No report of any patient issues.

Manufacturer Narrative

Lot number: the lot number was not provided.Therefore the expiration date is unknown.Manufacture date: the lot number was not provided.Therefore, the manufacture date is unknown.Sorin group received a report that while removing the stylet from the catheter, the handle and metal inner support wire came out leaving the blue outer portion in place.This was not noticed and the vent tubing was attached.During the case, the vent had to be run at a higher pump rate.No other problems occurred as a result of the stylet part in the catheter.No report of any patient issues.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group received a report that while removing the stylet from the catheter, the handle and metal inner support wire came out leaving the blue outer portion in place.This was not noticed and the vent tubing was attached.During the case, the vent had to be run at a higher pump rate.No other problems occurred as a result of the stylet part in the catheter.No report of any patient issues.The complained device was returned to sorin group usa for evaluation.Visual inspection of the returned part found that the stylet had not been inserted far enough into the handle as stated in the specifications.Five cannula from a different lot (15023000115) were pulled from inventory for further testing.The 5 cannula were subjected to a tensile strength test, and were pulled to failure.Per the vendor specifications, the connection between the stylet and handle are required to sustain at least 15n (3.37lb) of force.The units pulled from inventory all sustained at least 26.73lbs of force, significantly exceeding the specification.This issue was the result of a supplier manufacturing error.A supplier quality notification will be issued in response to this conclusion, and a follow-up report will be filed upon receipt of the supplier's completed investigation report.

Manufacturer Narrative

Sorin group received a report that while removing the stylet from the catheter, the handle and metal inner support wire came out leaving the blue outer portion in place.This was not noticed and the vent tubing was attached.During the case, the vent had to be run at a higher pump rate.No other problems occurred as a result of the stylet part in the catheter.No report of any patient issues.The complained device was returned to sorin group usa for evaluation.Visual inspection of the returned part found that the stylet had not been inserted far enough into the handle as stated in the specifications.Five cannula from a different lot (15023000115) were pulled from inventory for further testing.The 5 cannula were subjected to a tensile strength test, and were pulled to failure.Per the vendor specifications, the connection between the stylet and handle are required to sustain at least 15n (3.37lb) of force.The units pulled from inventory all sustained at least 26.73lbs of force, significantly exceeding the specification.This issue was the result of a supplier manufacturing error.A supplier quality notification was issued in response to this conclusion.The supplier investigation found that the during the stylet handle molding process, the stylet tube and wire were not secured in place, which could cause the reported defect if the components shift during molding.The supplier updated the workflow on february 1st, 2016 to add a jig to the mold to keep overall length of the stylet components consistent.This action will help to prevent the blue stylet tube from shifting and will allow a proper mold between the stylet and the handle.

• Brand Name: VENTR CATH PVC 2 POS LST 18F
• 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; 14401 w. 65th way; arvada CO 80004
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 4912823
• MDR Text Key: 6433702
• Report Number: 1718850-2015-00245
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K981601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,distributor,health profess
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VT-53218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other