MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN VELOSORB FAST; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	CV-917
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Radiation Exposure, Unintended (3164); No Code Available (3191)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, at the end of the perineal suture in an obstetrics surgery, the thread loosened from the curved needle and the needle became disengaged in the subcutaneous tissue of the patient's buttock.The physician therefore defeated the suture and performed a radiological examination to recover the needle.An x-ray was performed on the same date as the surgery.The doctor had to use a new suture and put the patient under prophylactic antibiotic therapy to complete the case.The patient was alive with no injury.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one device.Needle was received bent.The needle was disengaged from the suture.Upon microscopic inspection of the needle, instrument marks were observed near the bent site and on the swaged end of the needle.However, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Replication of this damage may occur by grasping the needle improperly which can damage the needle as observed.It is recommended that the needle be grasped from the needle body, where the wire is of a full diameter and significantly stronger.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
Additional Manufacturer Narrative
This report is filed in error and (b)(6) would be filing all subsequent communications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VELOSORB FAST
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06473
• MDR Report Key: 7019213
• Report Number: 1219930-2017-08667
• Device Sequence Number: 127191
• Product Code: GAM
• UDI-Device Identifier: 20884521151656
• UDI-Public: 20884521151656
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K120556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: CV-917
• Device Catalogue Number: CV-917
• Device Lot Number: 16120122X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 01/24/2018; 01/24/2018
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 02/23/2018; 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention