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

Model Number	IPN914269
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reported issue: the balloon burst during the robot assisted radical prostatectomy.Therefore, the device was replaced with a new one.Nothing fell/remained in the patient.
Additional Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit of 410944s weckvista access balloon port 10mmx53mm for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample appears used, as there is biological material present on the device.The balloon was found to have three holes in a line along a seam at its proximal end.Based on the condition of the returned sample and the inspection process for each device during manufacturing, the damage appears to be caused when the device was scraped during the procedure.Therefore, unintentional user error caused or contributed to this issue.The device history review for manufacturing site: according to gs-0168tec, each part produced is tested as a control process in normal production, and a completed part must remain inflated for a minimum of 30 minutes.Additionally, also each part produced is 100% inspected by passing through a gage which helps to detect the overinflation condition on the balloon assembly.This information supports the probable root cause of unintentional user error.The device history review for the product weckvista access balloon port 10mmx53mm lot# 73b2100633 investigation did not show issues related to the complaint.The ifu for this product, l02709 rev02, was r eviewed as a part of this complaint investigation.The ifu informs the user, "fill the provided syringe with 10 cc of sterile liquid or 15 cc of air.Attach the syringe to the check valve and inflate slowly.Caution: over-inflation of the balloon may cause it to r upture.Note that 10 cc of fluid or 15 cc of air will completely inflate the balloon and further inflation is unnecessary and will increase the risk of balloon rupture." the ifu also states, "to ensure smooth insertion, avoid inserting instruments at an angle.Always attempt to insert instrumentation straight down the cannula.A corrective action is not required at this time as it appears that unintentional user error caused or contributed to this event." the reported complaint of burst - balloon was confirmed based upon the sample received.Based on the observed damage, the device appears to have been scratched/scraped during the procedure.All balloon ports are 100% inspected for proper inflation during the inspection process.It is unlikely that this type of damage was present at the time of manufacturing.A device history record review was performed and showed no evidence to suggest a manufacturing related issue.Based upon the damage observed, it appears that unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
Reported issue: the balloon got burst during the robot assisted radical prostatectomy.Therefore, the device was replaced with a new one.Nothing fell/remained in 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16079292
• Report Number: 3003898360-2022-00918
• Device Sequence Number: 15026362
• Product Code: GCJ
• UDI-Device Identifier: 14026704645210
• UDI-Public: 14026704645210
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2022

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: 02/16/2023
• Device Model Number: IPN914269
• Device Catalogue Number: 410944S
• Device Lot Number: 73B2100633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 12/30/2022
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2021
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown