MAUDE Adverse Event Report: MIZUHO AMERICA; ANEURYSM CLIP

Catalog Number 17-001-68

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Aneurysm (1708); Stroke/CVA (1770); High Blood Pressure/ Hypertension (1908)

Event Date 12/01/2016

Event Type  Injury  

Event Description

Aneurysm clip came off the clip applier and was believed to have flown off field.Clip was found in the brain by post-op xray.Returned to surgery the next day for removal.Clip applier instrument, device not available for eval, device has been reprocessed and reused.Device age is unk.

• Type of Device: ANEURYSM CLIP
• Manufacturer (Section D): MIZUHO AMERICA; 30057 ahern ave; union city CA 94587
• MDR Report Key: 6219403
• MDR Text Key: 63844135
• Report Number: 6219403
• Device Sequence Number: 1
• Product Code: HCH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 17-001-68
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2016
• Distributor Facility Aware Date: 12/02/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2016
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ANAURYSM CLIPS CAT# 17-001-01, CLIP APPLIERS INFO,; ANAURYSM CLIPS CAT# 17-001-03; ANAURYSM CLIPS CAT# 17-001-08; PRODUCT NUMBERS UNK, SAME MFR AND ADDRESS.
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 41