MAUDE Adverse Event Report: EDWARDS LIFESCIENCES VASCUSHUNT (WITH STOPCOCKS) SILICONE BALLOON SHUNT; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number T3103AS

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned to edwards for evaluation.The evaluation is anticipated but has not yet begun.A supplemental report will be submitted upon completion.

Event Description

Edwards received notification that during use of the carotid shunt, a hole was observed in the balloon, making it impossible to use it.The procedure was concluded without using it and a primary anastomosis was made.The patient did not experience any injury due to this event.The device was returned for evaluation.

Manufacturer Narrative

Customer complaint of leakage was confirmed.As received, a pin hole leakage was observed at the 15mm balloon (blue valve) side of the cardioplegia trifurcation section during inflation.The 9mm (white valve) balloon inflated clear, concentric and remained inflated for 5 min without leakage.No other visual damage, contamination, or other abnormalities were found on product.Engineering evaluation has been opened and assigned for further investigation.Packaging conditions were not reported, so it is unknown if the product damage was caused during shipping.As reported, the device was prepared according to the ifu.However, it still remains a possibility that the device was unintentionally damaged while being prepared for use.A manufacturing defect was not identified a definitive root cause could not be identified.The ifu warns, ¿do not use if device shows signs of damage (i.E., cuts, kinks, crushed areas), or if package is damaged or open.¿ the device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.

Event Description

Edwards received notification that before use of a carotid shunt model t3103as, a hole was observed in the balloon.Prepping of the cannula was done as per ifu and a hole was observed in the shunt so the device was not inserted/placed in the patient.The procedure was concluded without using it and a primary anastomosis was made.The patient did not experience any injury due to this event.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: VASCUSHUNT (WITH STOPCOCKS) SILICONE BALLOON SHUNT
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 7516152
• MDR Text Key: 108734125
• Report Number: 3008500478-2018-00068
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K860988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Model Number: T3103AS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Manufacturer Received: 04/21/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 05/21/2018; 07/11/2018; 07/23/2020
• Supplement Dates FDA Received: 06/01/2018; 07/17/2018; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR