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

Catalog Number 412944

Device Problem Material Rupture (1546)

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

Event Date 11/14/2023

Event Type  malfunction  

Event Description

It was reported that "the balloon got burst during a urological surgery.Therefore, the device was removed and replaced with a new one to complete the procedure.Nothing fell/remained in the patient, and no injury to the patient was reported".The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed as no lot number was reported.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "the balloon got burst during a urological surgery.Therefore, the device was removed and replaced with a new one to complete the procedure.Nothing fell/remained in the patient, and no injury to the patient was reported".The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).The reported complaint of "burst - balloon" could not be confirmed based upon the sample received.Upon functional inspection, no leak was observed.The tecate manufacturing site was contacted as part of this investigation.The manufacturing site confirmed that no functional defect could be concluded for the returned sample because the balloon inflated properly.A dhr review was performed with no evidence to suggest a manufacturing related cause.Teleflex will continue to monitor and trend on complaints of this nature.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18169533
• MDR Text Key: 328532582
• Report Number: 3003898360-2023-01552
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04026704559763
• UDI-Public: 04026704559763
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 412944
• Device Lot Number: 73E2200603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1