MAUDE Adverse Event Report: COOK VASCULAR INC; DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported: "patient presented with porta-cath device in rt.Arm that was non-functional.Phlebotomist unable to aspirate or instill.X-rays revealed fracture line about 1 cm from reservoir.Majority of line located in rt.Atrium, rt.Ventricle and pulmonary artery.This complication has a 60% risk of mortality." no additional information was available at the time of this report.
Additional Manufacturer Narrative
Brand name) vital-port detached silicone catheter with introducer set and obturator titanium infusion port.Common device name) dwf catheter, cannula and tubing, vascular, cardiopulmonary bypass.Pma#) k931586.Investigation - evaluation a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions and quality control was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The device is shipped with an instruction for use (ifu) that describes the intended use; specific items are addressed such as: warnings: "introduction of the catheter into the subclavian vein using standard percutaneous techniques may subject the catheter to periodic compression forces within the narrow costoclavicular space between the clavicle and the first rib.Reported complications from repeated subclavian compression include catheter pinch off syndrome, catheter fracture, and catheter shear followed by embolization of the distal portion." based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Common Device Name: DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 6176535
• Report Number: 2522007-2016-00015
• Device Sequence Number: 13566728
• Product Code: DWF
• UDI-Device Identifier: 00827002264724
• UDI-Public: (01)00827002264724(17)180930(10)N131902
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K931586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IP-S5116W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 03/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention