MAUDE Adverse Event Report: MEDTRONIC MEXICO BIO-MEDICUS LIFE SUPPORT TM; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number LS96218-021

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/12/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

Medtronic received information that during use, the customer stated that following re-tightening of the attachment point of the bio-medicus arterial jugular cannula after 15 days of use and insertion in the patient, that the cannula sheared across the metal frame of the device.This cannula which has a silicone ring present on the device was used to attach a suture close to the insertion point to fix the cannula.The customer explained that they actually used two attachment points for the cannula.A knot was made on the part the cannula at the point of insertion (silicone ring), but also at a point at a distance of about 5 then 10cm away to secure fixation of the cannula.This additional attachment point was necessary due to mobilization of the patient.In this case, it was necessary to replace the additional suture fixation, as it had been in place for 15 days and had become too loose.A knot was therefore made on the jugular cannula.The customer said the suture was passed twice around part of the cannula, and probably damaged (cut through) the cannula.A thin stream of blood occurred and then a significant hemorrhage appeared.The cannula had sectioned.The patient, already hemodynamically very unstable and impossible to ventilate, died as a result of hemorrhagic shock (blood loss) caused by the sectioning of the cannula.Patient was overweight, covid+ and had been receiving treatment for high blood pressure.

Event Description

Medtronic received information that during use, the customer stated that following re-tightening of the attachment point of the bio-medicus arterial jugular cannula after 15 days of use and insertion in the patient, that the cannula sheared across the metal frame of the device.This cannula which has a silicone ring present on the device was used to attach a suture close to the insertion point to fix the cannula.The customer explained that they actually used two attachment points for the cannula.A knot was made on the part the cannula at the point of insertion (silicone ring), but also at a point at a distance of about 5 then 10cm away to secure fixation of the cannula.This additional attachment point was necessary due to mobilization of the patient.In this case, it was necessary to replace the additional suture fixation, as it had been in place for 15 days and had become too loose.A knot was therefore made on the jugular cannula.The customer said the suture was passed twice around part of the cannula, and probably damaged (cut through) the cannula.A thin stream of blood occurred and then a significant hemorrhage appeared.The cannula had sectioned.The patient, already hemodynamically very unstable and impossible to ventilate, died as a result of hemorrhagic shock (blood loss) caused by the sectioning of the cannula.Patient was overweight, covid+ and had been receiving treatment for high blood pressure.

Manufacturer Narrative

Medtronic investigation: analysis of the returned complaint cannula found the suture ring still in place along with a suture.A medtronic technician and r / d engineer were able to estimate which side of the catheter was against the patients neck with the opposite side being exposed to the secondary suture.This seems to support a relatively clean ¿cut¿ likely due to suture strangulation on one side of the body and tearing of catheter material with the spring cut on the opposite side when the product was removed from the patient.There is no evidence of manufacturing defects in the product (adjacent walls appear normal and fully formed).Based on what medtronic was able to observe, after 15 days the loose secondary anchoring suture was tightened and that this tightening resulted in a breach of the cannula wall while on pump.In a vv procedure, this catheter would be returning blood to the patient.Breaching the wall would result in loss of blood through the opening.After analysis this complaint was determined to a use-related issue; according to the instructions for use, adverse effects like major blood loss or death could be associated with the use of the product due to an incorrect suturing.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.A review of complaints received for similar model numbers found no similar occurrences.Assessment against the medtronic risk management file document indicates that the current risk zone does not exceed the risk zone predicted; therefore, no capa will be initiated at this time.This investigation was completed with the information that was provided.If additional information is received, this investigation will be reopened if deemed necessary.Medtronic will continue to monitor for future occurrences and trends.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: BIO-MEDICUS LIFE SUPPORT TM
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 11284369
• MDR Text Key: 230425506
• Report Number: 9612164-2021-00518
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: UNDER REVIEW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

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: 10/14/2023
• Device Model Number: LS96218-021
• Device Catalogue Number: LS96218-021
• Device Lot Number: 220948011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Weight: 125