MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON POLYSORB BRAIDED ABSORBABLE SUTURE 1 4 METRIC 36"; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number CL925

Device Problems Break (1069); Component Falling (1105)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 07/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional patient information was reported to be not available.Unintended radiation exposure was selected due to the report of the utilization of the image converter.Product return was originally reported to be available, however as of yet no product has been received.The information including in this report is what has currently been made available by the user account.Any additional information has been requested of the account, however, as of yet no additional information has been provided.Should additional information become available, the file will be updated.

Event Description

According to the reporter; during a urological procedure the suture thread in use broke and the portion of the thread that remained attached to the needle fell into the patient.Patient details were not made available however an image converter had to be used in order to locate and retrieve the needle, which required the procedure time to be extended by more than 30 minutes.It was provided that there was no injury to the patient including, no blood loss, no tissue damage or loss, no extension of an incision and no change of procedure.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of fifteen sealed suture devices.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, medical affairs review of the complaint file, and an evaluation of the returned sample.The initial tactile and microscopic inspection of the sample by the pmv investigator noted no abnormalities.A tensile test was performed on the sealed samples and the results exceeded the specifications for this product.The returned samples were found to meet quality release specifications after application in the clinical setting and the reported condition was not confirmed.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Brand Name: POLYSORB BRAIDED ABSORBABLE SUTURE 1 4 METRIC 36"
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: matthew amaral ; 60 middletown ave; north haven, CT 06473 ; 2034926373
• MDR Report Key: 5915493
• MDR Text Key: 53515526
• Report Number: 1219930-2016-00921
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K963253
• 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,Followup,Followup
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: CL925
• Device Catalogue Number: CL925
• Device Lot Number: A5F1247EX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention