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

Model Number 94533

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problem Hematoma (1884)

Event Date 06/01/2000

Event Type  malfunction  

Manufacturer Narrative

Conclusion: medtronic cannot confirm or deny the complaint of hematoma the coronary sinus as no product has been returned to date.A root cause of this occurrence cannot be determined without returned product.The device history record could not be reviewed as no lot number was provided.Complaints received for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.If the product is returned, this pe will be reopened and the analysis and investigation will be updated.There were no adverse patient effects as a result of this occurrence.Medtronic has made its supplier aware of this occurrence and will continue to monitor for future occurrences and trends per the product quality meetings procedure.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 via literature regarding coronary sinus (cs) injuries following retrograde cardioplegia.All data were collected retrospectively from a single center over three years.The study population included 620 out of 942 patient where a retrograde coronary sinus cardioplegia catheter was used for administration of retrograde cardioplegic solution.Among all patients, coronary sinus injuries were encountered in 4 patients (0.65%).Based on the available information, these adverse effects may have been associated with medtronic product.There were 3 men and 1 woman, their ages were 45, 56, 59, 67 years.All 4 underwent elective coronary artery bypass surgery.In all 4 cases, retrograde cardioplegia was used to complement antegrade cardioplegia.Direct palpation or visualization of the cannula in the cs, as well as monitoring cs pressure, were used to confirm correct positioning of the cannula.In these 4 cases, there was difficulty in introducing the cannula into the cs and forceful insertion was probably used.In 2 cases, a feeling that the cs had given way was noted during insertion of the cannula, massive venous bleeding was observed coming from the back of the heart, and the tip of the cannula was seen coming out from the coronary sinus.In these 2 cases, the cs was torn.The first tear, measuring 1.5 cm in length, was successfully repaired with continuous 7/0 polypropylene suture after a little trimming of the coronary sinus edge.The second tear was larger (2.5 × 0.5 cm) and there was little of the cs edge to suture (complete laceration).It was decided to use a fresh autologous pericardial patch for the repair.The repair was successful in both cases and the operation continued in the usual fashion.Medtronic product may have been associated with the reported adverse events.These events will be captured in pli-10.In the other 2 cases, hematomas of 2 × 3 cm2 and 4 × 5 cm2 were observed at the back of the heart around the coronary sinus, there was no bleeding, and the cannula was in the correct place in the cs.In these 2 cases where intact sub-epicardial hematomas surrounded the cs, it was decided to leave them undisturbed.The retrograde cs cannula was withdrawn from the cs in each case and the retrograde route was abandoned.No product performance issues were reported.Medtronic product is not associated with these adverse events.These events will be captured in pli-20.All 4 patients had an uneventful postoperative course and echo-doppler studies on the 5th postoperative day were satisfactory.After one month, additional echo-doppler studies were carried out and these demonstrated no abnormalities.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Correction a2: patient age updated.Age is approximate (average of patient group).Correction b2: required intervention to prevent permanent impairment was selected in the initial report (# 9612164-2023-03072) in error.No intervention was required to treat the insertion difficulties.Correction d3: manufacturer address updated.Correction h6: device code (fdd/annex a) updated.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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

Literature article details: ahmed f elwatidy.¿coronary sinus injuries following retrograde cardioplegia¿.Asian cardiovascular thoracic annals, vol.8, no.2, 2000.Doi.Org/10.1177/021849230000800206 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: RCSP RETROGRADE 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17285517
• MDR Text Key: 318660081
• Report Number: 9612164-2023-03072
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K171979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 94533
• Device Catalogue Number: 94533
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 07/18/2023; 07/18/2023
• Supplement Dates FDA Received: 07/18/2023; 07/18/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male