MAUDE Adverse Event Report: PERFUSION SYSTEMS BIOMEDICUS ONE PIECE FEMORAL VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number CB96825-014

Device Problems Fracture (1260); Leak/Splash (1354)

Patient Problem Tissue Damage (2104)

Event Date 12/08/2016

Event Type  Injury  

Manufacturer Narrative

Product has not yet been returned to medtronic for analysis.The investigation is in progress.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 30 minutes into a case, the customer noted this cannula began to leak.The surgeon sealed the leak and chose to continue using the cannula throughout the case.When the cannula was removed from the patient, exposed wire from the cannula body damaged the femoral artery.The physician used a blood vessel prosthesis to anastomose the vessel.There were no further patient issues noted and the patient was reported to be in stable condition post-operatively.Product return is expected.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality assurance laboratory, the cannula was returned in two pieces.The returned product appears broken.Medtronic's investigation is still in progress.Additional information confirming the model number of the device was received.

Event Description

Medtronic received information that 30 minutes into a case, the customer noted this cannula began to leak.The surgeon sealed the leak and chose to continue using the cannula throughout the case.When the cannula was removed from the patient, exposed wire from the cannula body damaged the femoral artery.The physician used a blood vessel prosthesis to anastomose the vessel.There were no further patient issues noted and the patient was reported to be in stable condition post-operatively.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual inspection of the used device showed the device was in two pieces.The investigation remains in progress.

Event Description

Medtronic received information that the customer did not notice any abnormalities with the device prior to use.Thirty minutes into a case, the customer noted this cannula broke and began to leak.The surgeon chose to seal the leak and continued to use the cannula, for another hour and a half, until the case was completed.When the cannula was removed from the patient, the exposed wire from the cannula body cut the femoral artery.The physician used a blood vessel prosthesis to anastomose the vessel.There were no further patient issues noted and it was reported the patient was in stable condition post-operatively.Additional information was received indicating the device had been re-sterilized prior to use.

Manufacturer Narrative

Conclusion: after investigation at medtronic and its supplier, the complaint of a broken cannula device was confirmed.Investigation indicates that the damage may be a result of the use of tools on the device.There are no tools or equipment that are used during the manufacture of the device that may have lead to this occurrence.Damage to the device of this nature would have been identified during the manufacture and inspection of the device.The packaging and instructions for use of this product state that this device is not to be re-sterilized, and the customer stated the product was re-sterilized.This may have attributed to the degradation and subsequent damage of the cannula body.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: BIOMEDICUS ONE PIECE FEMORAL VENOUS 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: 6219362
• MDR Text Key: 63755231
• Report Number: 2184009-2017-00001
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K872033
• 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,Followup,Followup,Followup
• Report Date: 02/17/2017

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: 09/30/2016
• Device Model Number: CB96825-014
• Device Catalogue Number: CB96825-014
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 01/03/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 02/17/2017
• Supplement Dates FDA Received: 01/23/2017; 02/17/2017; 03/10/2017; 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR