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

Model Number 94315T

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

Patient Problems Cardiac Perforation (2513); Vascular System (Circulation), Impaired (2572); Vascular Dissection (3160)

Event Date 01/30/2015

Event Type  Injury  

Manufacturer Narrative

Citation: hiroyuki tsukui.Left atrial dissection related to retrograde cardioplegia cannula insertion.Heart vessels.2016 may;31(5):819-21.Doi: 10.1007/s00380-015-0634-8.Earliest date of publish used for event date.The model and catalog number were arbitrarily chosen, as no unique device identifier (model/lot) numbers were provided.The 510k number was populated using this arbitrary number.Without this information it could not be determined whether these observations have been previously reported.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 left atrial dissection (lad) related to retrograde cardioplegia cannula insertion.This was a case study on a (b)(6) year old male patient, who underwent cardiopulmonary bypass using a medtronic dlp cannula with auto inflate cuff for retrograde cardioplegia.The cannula was inserted into the coronary sinus (cs) with direct vision and no issues were observed during insertion.While weaning from bypass, a bulge on the posterior wall of the left atrium was noted causing compromised blood flow, and at this point a lad was diagnosed.The customer suggested the tip of the cannula may have perforated the cs due to the excessive traction on the heart to expose the mitral valve during surgery, and the infusion of cardioplegia solution ultimately caused the lad.The lad was drained, blood flow returned to normal, and the patient was weaned from bypass and discharged successfully.

• Brand Name: AUTO INFLATE RCSP
• 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: 7167418
• MDR Text Key: 96470073
• Report Number: 2184009-2018-00001
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2018

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: 94315T
• Device Catalogue Number: 94315T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/05/2018
• 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: 63 YR