MAUDE Adverse Event Report: PERFUSION SYSTEMS CARMEDA BIOMEDICUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number CB96535-021

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that several weeks after a procedure to repair a dissection of the ascending aorta, the patient had a computed tomography (ct) scan.The ct scan showed part of a cannula guidewire remained in the patient's body.The customer believed the guidewire had broken during removal of the introducer, from the cannula used in the surgery several weeks prior.An attempt to remove the guidewire was unsuccessful and the guidewire remains inside the patient.The current patient status is stable and the course of action to remove the guidewire at this time is unknown.

Manufacturer Narrative

Conclusion: after investigation, the complaint of damage or bending of the guidewire was confirmed via image review.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.The customer confirmed that the guide wire was removed while the introducer needle remained in place; this needle can cause damage to the guide wire.After discussion with medtronic marketing, research <(>&<)> development and clinical representatives from the office of medical affairs, it was determined that damage of this nature could have been caused during the use of the guide wire.The instructions for use for this model number caution the user "do not withdraw spring guide wire back into needle as shearing of the guide wire may result.Always remove the needle first".Medtronic will continue to monitor for future occurrences.At the current time, no additional attempts are scheduled to remove the guidewire from the patient.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CARMEDA BIOMEDICUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6987034
• MDR Text Key: 90547153
• Report Number: 2184009-2017-00040
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K884129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: CB96535-021
• Device Catalogue Number: CB96535-021
• Device Lot Number: 212114580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2017
• Initial Date FDA Received: 10/30/2017
• Supplement Dates Manufacturer Received: 11/21/2017
• Supplement Dates FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/15/2016
• 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): Life Threatening; Required Intervention
• Patient Age: 32 YR