MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-MEDICUS FEMORAL VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 96830-112

Device Problems Detachment Of Device Component (1104); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/18/2016

Event Type  Injury  

Manufacturer Narrative

With the available information and without the return of the product, medtronic is unable to definitively conclude the root cause of the reported issue at this time.

Event Description

Medtronic received information that after the completion of a liver transplant procedure, the patient was complaining of a lump in the right neck region.The patient was discharged from the hospital.Several months following, the patients right neck region was examined prior to a liver biopsy and the suture collar from the cannula used in the procedure months prior was discovered.The suture collar was successfully removed.Medtronic has attempted to gain current patient status and no information has been received to date.The customer noted that during the initial procedure they did not recognize the object in question as a suture collar and consequently they inserted the suture collar subcutaneously.

• Brand Name: BIO-MEDICUS 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: 7041072
• MDR Text Key: 92322572
• Report Number: 2184009-2017-00043
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143083
• 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
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96830-112
• Device Catalogue Number: 96830-112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Weight: 45