MAUDE Adverse Event Report: PERFUSION SYSTEMS CARDIOBLATE SURGICAL ABLATION XL PEN; SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE

Model Number 60814

Device Problem Energy Output To Patient Tissue Incorrect (1209)

Patient Problem Tissue Damage (2104)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, the device was tested with no issues observed.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Analysis determined that the product functioned as expected.If the user administers too much energy to one location of tissue, damage may be a result.With the available information, it is suspected that user technique contributed to this event.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 that during a procedure, the customer reported too much energy was generated by this cardioblate ablation pen which caused myocardial tissue damage.Stitches were used to repair the tissue damage.The device was used throughout the remainder of the procedure and the patient had no additional adverse effects.

• Brand Name: CARDIOBLATE SURGICAL ABLATION XL PEN
• Type of Device: SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
• 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: 6902460
• MDR Text Key: 87718768
• Report Number: 2184009-2017-00036
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K070288
• 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: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 60814
• Device Catalogue Number: 60814
• Device Lot Number: 2016090663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2016
• 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