MAUDE Adverse Event Report: TELEFLEX MEDICAL WECKVISTA ACCESS BALLOON PORT 12MMX70MM; LAPAROSCOPE, GENERAL & PLASTIC

Model Number IPN914249

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device history review for the product weckvista access balloon port 12mmx70mm lot # 73c2200037 investigation did not show issues related to the complaint.The device investigation is pending and the results will be submitted in a follow-up report.

Event Description

Reported issue: the balloon burst during the second half of the operation.Therefore, the device was removed and replaced with the device of other company to complete the procedure.Nothing fell/remained in the patient, and no injury to the patient occurred.

Manufacturer Narrative

(b)(4).The customer returned one unit of 412944 weckvista access balloon port 12mmx70mm 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 a tear along the length of the balloon.Scrape marks were observed on the device beside the tear.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.Per the manufacturing site, 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 (the length of the conveyor).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.Per dhr the weckvista access balloon port 12mm x70mm lot # 73c2200037 was manufactured on 03/01/2022 a total of 154 pieces.Lot was released on 03/31/2022.Dhr investigation did not show issues related to complaint.The ifu for this product, was reviewed 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 rupture.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.The balloon was found to have a tear along the length of the balloon.Scrape marks were observed on the device beside the tear.The balloon was found to have three holes in a line along a seam at its proximal end.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 o f 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 Description

Reported issue: the balloon burst during the second half of the operation.Therefore, the device was removed and replaced with the device of other company to complete the procedure.Nothing fell/remained in the patient, and no injury to the patient occurred.

• Brand Name: WECKVISTA ACCESS BALLOON PORT 12MMX70MM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16550887
• MDR Text Key: 311378916
• Report Number: 3003898360-2023-00325
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 14026704645227
• UDI-Public: 14026704645227
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: IPN914249
• Device Catalogue Number: 412944
• Device Lot Number: 73C2200037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED