MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-MEDICUS NG 23 FR ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 96570-123

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoxia (1918); Ischemia (1942); Sepsis (2067)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

Literature article details: title: using near-infrared reflectance spectroscopy (nirs) to assess distal-limb perfusion on venoarterial (v-a) extracorporeal membrane oxygenation (ecmo) patients with femoral cannulation authors: killian patton-rivera, james beck, kenmond fung, christine chan, matthew beck, hiroo takayama and koji takeda journal: perfusion, 2018, vol.33(8) 618 ¿623 doi: https://doi.Org/10.1177/0267659118777670.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a pilot study to evaluate the usefulness of non-invasive lower-limb oximetry, using near-infrared reflectance spectroscopy (nirs) to detect limb ischemia.All data were collected from a single center between june 2016 and january 2017.The study population included 25 patients (predominantly female; mean age 55 years), medtronic biomedicus femoral cannulae were used as part of the veno-arterial extracorporeal membrane oxygenation (va-ecmo) circuit (serial numbers not provided).Among all patients, two deaths occurred.These patients had do not resuscitate status.Based on the available information, none of the deaths were attributed to medtronic product.Among all patients, adverse events included: one patient was diagnosed with sepsis and malposition of their left ventricular assist device (lvad), six patients had hypoxia to the lower limb and the patients had sto2s of less than 50% for longer than four minutes.Three patients were diagnosed with cannula-related obstruction to antegrade flow.All three patients had a sto2 differential greater than 15%.Each patient received a distal perfusion cannula and the sto2s rose to normal levels above 60% following insertion.One of these patients still required a below-the-knee amputation of the cannulated leg due to a long period of ischemia while the surgeons stabilized the patient before nirs pads could be attached.This was the only incidence of surgical intervention for distal-limb ischemic complications in this cohort of patients.Based on the available information, the hypoxia to the lower limb and sto2 levels may have been attributed to medtronic product.Among all patients, no device malfunctions occurred.No additional adverse patient effects or product performance issues were reported.

• Brand Name: BIO-MEDICUS NG 23 FR ARTERIAL 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: 10711937
• MDR Text Key: 212321097
• Report Number: 2184009-2020-00069
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2020

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: Health Professional
• Device Model Number: 96570-123
• Device Catalogue Number: 96570-123
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/21/2020
• 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): Required Intervention; Disability
• Patient Age: 55 YR