MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC PREMIUM SURGICLIP* S-9.0 TITANIUM; CLIP, IMPLANTABLE

Model Number 134046

Device Problems Difficult or Delayed Positioning (1157); Difficult to Advance (2920); Material Deformation (2976)

Patient Problems Tissue Damage (2104); Perforation of Vessels (2135)

Event Date 10/20/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: during a coronary artery bypass grafting (cabg) procedure, the surgeon was harvesting the left radial artery.The device failed to apply the clips.The clips were not immediately engaging into the jaws but was taking 2-3 attempts of squeezing the handle.As a result, the jaws of the device were acting as shears and cut through the side branches of the radial.Some clips were able to load and fire from the device, but most clips did not form correctly.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5270323
• MDR Text Key: 32770172
• Report Number: 2647580-2015-00863
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K853650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 134046
• Device Catalogue Number: 134046
• Device Lot Number: P5E0481CVX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR