MAUDE Adverse Event Report: SORIN GROUP USA, INC. AORTIC ARCH CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	LR-XXXXX
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.Through follow-up communication with the initial reporter, sorin group learned that the device was dipped into an isotonic saline solution (nacl) prior to use.A photograph provided by the customer confirmed the reported issue.If any additional information relevant to the reported event is received, it will be provided in a supplemental report.Photo provided; device availability unk.
Event or Problem Description
Sorin group received a report that the ink printed on the side of the aortic arch cannulae began to flake off into the surgical area during a procedure.There was no report of patient injury.
Additional Manufacturer Narrative
Seven unused low profile, wire-reinforced dual stage venous return catheters were returned to livanova usa for evaluation.The individual complaint catheter was not returned.The returned catheters were highly discolored, as livanova italy had processed and decontaminated all seven devices using gamma radiation treatment before shipment to livanova usa.Visual inspection of the returned catheters revealed that all units had clear, readable printing.Visual inspection of the primary packaging and the catheters themselves revealed no loose flakes of ink or ink smears.A tactile test did not produce ink flakes or ink smears.The returned product conformed to specifications; no defects were found.Engineering tests were performed on 20 representative catheters to study the effect of absent or inadequate heat fix of the ink.Ten devices were ink stamped without the heat fix procedure and ten devices were ink stamped and manufactured properly.All were sterilized prior to testing, which included initial primary inspections, tactile testing, saline dipping, saline rubbing and isopropyl alcohol wipe-downs.At no time were loose flakes of ink or ink smears observed in either test group.The complaint could not be replicated.Over 38,000 lrd-611xx series products have been produced since the manufacturing of this product line began at livanova usa.The ink used on these catheters is also used company-wide on many other products.There have been no other issues ever reported for ink flaking, smearing or rubbing off.As the issue could not be reproduced, a root cause was not determined.

• Brand Name: AORTIC ARCH CANNULA
• 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: 6709865
• Report Number: 1718850-2017-00010
• Device Sequence Number: 1772033
• Product Code: DWF
• UDI-Device Identifier: 00803622104053
• UDI-Public: (01)00803622104053(240)LRD-61150(17)190228(10)1603900089
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K943934
• 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): 10/18/2017

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 Expiration Date: 02/28/2019
• Device Model Number: LR-XXXXX
• Device Catalogue Number: LRD-61150
• Device Lot Number: 1603900089
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 10/22/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1