MAUDE Adverse Event Report: TELEFLEX MEDICAL WECKVISTA ACCESS BALLOON PORT 10MMX53MM; LAPAROSCOPE, GENERAL & PLASTIC

Model Number	IPN914269
Medical Device Problem Codes	Burst Container or Vessel (1074); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the balloons burst.The balloon is pierced and cannot be inflated and therefore the device cannot be used.Use of another trocar from same reference and same lot.No impact on the staff or the patient".
Additional Manufacturer Narrative
(b)(4).Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.A device history record review was performed on the device with no evidence to suggest a manufacturing related cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the balloons burst.The balloon is pierced and cannot be inflated and therefore the device cannot be used.Use of another trocar from same reference and same lot.No impact on the staff or the patient".
Additional Manufacturer Narrative
(b)(4).The customer returned one-unit of 410944s weckvista access balloon port 10mmx53 mm for investigation.The returned sample was examined without magnification.Visual examination of the returned sample revealed that the balloon was partially detached from the cannula at the proximal end.The observed damage indicates that the balloon was over-inflated.Evidence of use in the form of biological material was present on the device.Per dhr the product weckvista access balloon port 10mmx53 mm lot # 73d2300596 was manufactured on 04/18/2023 a total of (b)(4) pieces.Lot was released on 05/04/2023.Dhr investigation did not show issues related to complaint.The reported complaint of "burst - balloon" was confirmed based upon the sample received.The device was returned with the balloon partially separated from the cannula at the proximal end.This damage is consistent with damage found when the balloon has been over-inflated.All balloon ports are 100% inspected for inflation during the inspection process.Based upon the damage observed, unintenti onal user error caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the balloons burst.The balloon is pierced and cannot be inflated and therefore the device cannot be used.Use of another trocar from same reference and same lot.No impact on the staff or the patient".

• Brand Name: WECKVISTA ACCESS BALLOON PORT 10MMX53MM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18112822
• Report Number: 3003898360-2023-01532
• Device Sequence Number: 18050716
• Product Code: GCJ
• UDI-Device Identifier: 04026704559787
• UDI-Public: 04026704559787
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/17/2025
• Device Model Number: IPN914269
• Device Catalogue Number: 410944S
• Device Lot Number: 73D2300596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: 11/16/2023; 04/08/2025
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 01/02/2024; 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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
• Patient Sex: Unknown