MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ATRIUM VEIN GRAFTTUNNELING SYSTEM; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number 26050

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 04/25/2016

Event Type  Death  

Manufacturer Narrative

Associated file: 1219977-2016-00166.On completion, a follow up report will be submitted.

Event Description

The physician reported he was performing a femoral-popliteal bypass on a patient that resulted in the patient having excessive bleeding from the popliteal vein.The patient became hemodynamically unstable and was transferred to the intensive care unit.He expired on (b)(6) 2016 of multi-organ failure.

Manufacturer Narrative

Engineering analysis: no lot numbers were provided so a review of manufacturing and qc records could not be performed.The territory sales manager performed a visual inspection of the tunneler kit; during this inspection he found no defects with the tunneler kit in question.The tips screwed on and off easily and had a smooth transition, no sharp edges or burrs were found.Photographs taken during this inspection have been reviewed and confirmed that there are no defects with the tunneler kit in question.Engineering summary: the engineering analysis could not determine the root cause of the incident.No defects were found during the inspection of the tunneler kit.All tunneler components are received with a certificate of compliance from the supplier.The tunneler kit instructions for use contain the following precautions: avoid damaging the threaded portions of the rods and tips through improper handling.The maquet tunneler requires disassembly, thorough cleaning, inspection and sterilization prior to each use.Do not soak the instruments in saline or bleach solutions, which may cause damage to the surfaces of the instruments.Do not use tunneler rod without compatible tip.Prior to use inspect instruments for the presence of foreign material including any residual tissue or debris, or any burrs or other surface anomalies that might injure the patient.Conclusion: based on the details of the event and the successful lot qualification test data, atrium can find no fault with the lot of tunneler kits in question.Clinical evaluation: the patient that requires a vascular graft has vascular tissue that may be hardened and calcified or very friable.Grafts are implanted surgically via an open incision and/or sub-cutaneous tunneling in certain applications.Surgeons undertaking such procedures are specialists in vascular disease and surgery and they have the skills necessary to be working in an operative suite and are supported by trained staff.In the event that an adverse situation occurs that is unexpected, an additional intervention may need to be performed.Any implantable device should be examined by the physician immediately prior to implant to confirm that the product is intact, that the threads of the component are undamaged and that the appropriate size is available.It is advised in the ifu of the product to contact atrium if these issues are noted.The ifu also advises that "avoid damaging the threaded portions of the rods and tips through improper handling.Tunneling can be one of the most traumatic parts of performing vascular surgery.Atrium designed its vascular tunneler system to minimize the trauma associated with tunneling.The atrium tunneler makes a tunnel that is the same size as graft being placed.

• Brand Name: ATRIUM VEIN GRAFTTUNNELING SYSTEM
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin rn, ccrn-k ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 5825292
• MDR Text Key: 50509559
• Report Number: 1219977-2016-00165
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 00650862260502
• UDI-Public: 00650862260502
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2016

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
• Device Operator: Physician
• Device Model Number: 26050
• Device Catalogue Number: 26050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2016
• Initial Date FDA Received: 07/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR