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

Catalog Number	412944
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem 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".
Additional 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.
Additional Manufacturer Narrative
(b)(4).Additional information received on 29 november 2023 states that "from the returned sample, the first sentence of the description is revised as follows: it was report that the ring clamp got broken during a urological surgery".The reported complaint of "broken - ring clamp" was confirmed based on the sample received.The ring clamp was observed to be broken and would not lock properly.An investigation was opened by the manufacturing site to further investigate this issue.A risk evaluation, quality alert, and supplier notification were implemented by the manufacturing site on 29-may-2023.A dhr review was performed with no evidence to suggest a manufacturing related cause.The returned sample was manufactured prior to this on 10-may-2022.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 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".

• Brand Name: WECKVISTA ACCESS BALLOON PORT 12MMX70MM
• 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: 18169495
• Report Number: 3003898360-2023-01553
• Device Sequence Number: 7716641
• Product Code: GCJ
• UDI-Device Identifier: 04026704559763
• UDI-Public: 04026704559763
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/14/2023

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: 05/09/2024
• Device Catalogue Number: 412944
• Device Lot Number: 73E2200360
• 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: 11/14/2023
• Supplement Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• 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