MAUDE Adverse Event Report: OSCOR INC. APTUS ENDOSYSTEMS 8.5F TOURGUIDE STEERABLE SHEATH; INTRODUCER, CATHETER

Model Number TG0855522

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Aneurysm (1708); Cardiac Perforation (2513)

Event Date 10/18/2016

Event Type  Injury  

Event Description

The physician attempted to insert the tourguide into the patient's distal aorta, to assist in cannulation during evar (endovascular aneurysm repair).During the index procedure (cannulation gate procedure) aortic perforation was discovered and the patient is undergoing surgery.The physician states the wire was not stiff enough.The customer reported this event occurred during normal use (i.E., reported event occurs during the life of an implanted device; after post-op and before explant).The device will not be returned, as it was reported as being lost.

Manufacturer Narrative

The device was used for treatment.The tourguide was not returned for analysis, as it was discarded.As a result, the allegations against this device (cardiac perforation) cannot be confirmed.A review of the device history record identified no rejects during manufacturing of this lot number.In addition, a review of complaints identified no other complaints against this lot number.The root cause could not be confirmed since it was not returned for evaluation.The investigation will focus on the potential for this failure mode and a review of product documentation.The following are potential known cause(s) for the reported failure: device not used by adequately trained personnel and/or does not follow instructions for use.Potential effect(s) may be: loss of functionality, no/poor deflection, difficulty manipulating and/or, positioning of device, or procedure delay.A review of risk for this failure mode identified the risk to be medium.Based on this investigation a capa is not required.Oscor will continue to monitor this device for complaint trends and risk.Controls are in place during manufacturing, also during qa in-process and final inspection procedures to ensure this device functions per design specifications.This is the first reported event for cardiac perforation.The aptus endosystems tourguide steerable sheath physician's manual informs the user of the following adverse events related to the use of the steerable sheath: air embolism, allergic reaction to contrast media, aortic puncture, arrhythmias, arteriovenous fistula formation, atrial septal defect, bleeding plexus injury, catheter entrapment, cardiac tamponade, coronary artery spasm and/or damage, dislodgement, dissection, endocarditis, heart block, hematoma formation, hemorrhage, hemothorax, infection, intimal tear, irregular heartbeat.Local nerve damage, mediastinal widening, myocardial infarction, pacemaker/defibrillator lead displacement, perforation, pericardial/pleural effusion, pneumothorax, pseudoaneurysm formation, pulmonary edema, stroke, subclavian artery puncture, thromboembolic events, thrombophlebitis, valve damage, vascular occlusion, vasovagal reaction, vessel damage/vessel trauma, vessel spasm.Precautions: transvenous device compatibility: use the steerable sheath only with compatible transvenous devices.Use the appropriate size sheath for the size of the transvenous device being utilized.Consequences of using the steerable sheath with incompatible devices may include the inability to deliver the transvenous device or damage to the transvenous device during delivery.

• Brand Name: APTUS ENDOSYSTEMS 8.5F TOURGUIDE STEERABLE SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer Contact: dorit segal ; 3816 desoto blvd.; palm harbor, FL 34683-1618 ; 7279372511
• MDR Report Key: 6127004
• MDR Text Key: 60846750
• Report Number: 1035166-2016-00175
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/01/2018
• Device Model Number: TG0855522
• Device Catalogue Number: TG0855522
• Device Lot Number: C8-04922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2015
• 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
• Treatment: STENT GRAFT ENDURANT
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR