MAUDE Adverse Event Report: ESTECH, INC. HEX MOUNT FLEXIBLE ARM W/ ATRIAL DRPRESSOR

Model Number 400-003

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  Death  

Event Description

Exposure of the mitral valve for replacement, break of the steel rope, device felt to 24 pieces, original number of pieces was unk, 1 piece was left in the thoracic cavity showed by xray on icu, no re-op because of hemodyn, instability, pt died unrelated to this event.

• Brand Name: HEX MOUNT FLEXIBLE ARM W/ ATRIAL DRPRESSOR
• Type of Device: HEX MOUNT FLEXIBLE ARM
• Manufacturer (Section D): ESTECH, INC.; san ramon CA
• Manufacturer Contact: 2603 camino ramon; ste 100; san ramon, CA 94583 ; 9258667111
• MDR Report Key: 3688202
• MDR Text Key: 4297611
• Report Number: 2953686-2014-00006
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/20/2014

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: 400-003
• Device Catalogue Number: 400-003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2014
• Initial Date FDA Received: 02/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Death