MAUDE Adverse Event Report: SORIN GROUP USA, INC. ESTECH EASYFLOW CANNULA WITH GUIDEWIRE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPUMONARY BYPASS

Catalog Number 103-310

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

Patient Problem Nicks, cuts or tears of dura or other tissues by device (1417)

Event Date 05/11/2015

Event Type  Injury  

Event Description

Sorin group received a report that an arterial cannula became lodged in an artery and tore the artery when the surgeon attempted to remove it.The surgeon repaired the artery without any pt complications.

Manufacturer Narrative

Sorin group received a repot that an arterial cannula became lodged in an artery and tore the artery when the surgeon attempted to remove it.The surgeon repaired the artery without any pt complications.The investigation is ongoing.A follow report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group received a report that an arterial cannula became lodged in an artery and tore the artery when the surgeon attempted to remove it.The surgeon repaired the artery without any patient complications.The complaint product was not returned to sorin group usa, as it was discarded by the customer.Unused inventory from the same lot was pulled for visual inspection and simulated use testing.Visual inspection of the produce before testing did not identify any defects or abnormalities.Two of the cannula pulled from inventory were used for simulated use testing.Blood was kept at 65 degrees celsius and circulated through the cannula for 6 hours while the cannula were submerged in a pool of warm bovine blood to simulate the exposure to the patient's body temperature.Visual inspection of the cannula after the simulated use tests found no defects.The cannula were identical in appearance to the units that had not undergone testing.The outer diameter was examined for (b)(4) of the devices pulled from inventory and all of the units were found to be within specification.All of the other cannula from this lot were visually inspected for surface integrity, spring exposure, ridges between the wires, uneven surface or any other surface abnormalities, and no issues were discovered.The supplier of this product was notified of the reported issue and conducted a review of the dhr, which did not identify any deviations or non-conformities relevant to the reported failure.No trend was identified for this type of issue.Sorin group will continue to monitor the market for trends.Eval'd product from inventory (same lot).

• Brand Name: ESTECH EASYFLOW CANNULA WITH GUIDEWIRE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPUMONARY 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: 4838080
• MDR Text Key: 5902686
• Report Number: 1718850-2015-00168
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 103-310
• Device Lot Number: 1506200119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 56