MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN VASCUFIL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	88864705-11V
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	01/24/2022
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, during a total anomalous pulmonary venous return procedure, after 10 stitches were sutured, the needle was clamped and passed through by a small bend.It was found that the needle tip was broken and missing 1mm.It was immediately searched but not found.Arm radiography was done, but the missing piece was not found and the surgeon decided to close the chest and sent the patient to the icu.It was confirmed that the fragment was left inside the patient's cavity.

• Brand Name: VASCUFIL
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13732060
• Report Number: 1219930-2022-00867
• Device Sequence Number: 19989540
• Product Code: GAT
• UDI-Device Identifier: 10884521101869
• UDI-Public: 10884521101869
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K990952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2022

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: 01/31/2026
• Device Model Number: 88864705-11V
• Device Catalogue Number: 88864705-11V
• Device Lot Number: A1B0780Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 03/11/2022
• Date Device Manufactured: 02/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 DA
• Patient Sex: Female