MAUDE Adverse Event Report: ATRICURE, INC. UNIVERSAL STABILIZER ARM, HERCULES 3

Model Number 001-401-152

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Not Applicable (3189)

Event Date 05/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4): the device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number for the hercules device was not reported or able to be subsequently ascertained.The complaint could not be confirmed.

Event Description

A medsun report was submitted by the facility on (b)(6) 2018 regarding a (b)(6) male patient who underwent an emergent coronary revascularization, left heart coronary and fractional flow reserve (ffr) of the ostial left anterior descending (lad) right femoral artery angiogram on (b)(6) 2018.A hercules retractor device was being used, the retractor broke and fell apart in the patient¿s chest.The instrument was changed, and a new device was obtained.An x-ray was taken at the end of the case, after direct communication with the radiologist to confirm no device pieces left behind the surgeon completed the procedure and closed patient¿s chest.There was no patient harm.The device was not returned for evaluation.

• Brand Name: UNIVERSAL STABILIZER ARM, HERCULES 3
• Type of Device: UNIVERSAL STABILIZER ARM, HERCULES 3
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5137554563
• MDR Report Key: 8207041
• MDR Text Key: 131787428
• Report Number: 3011706110-2018-00225
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D233474
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 001-401-152
• Device Catalogue Number: 001-401-152
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 53
• Patient Weight: 68