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

Model Number	IPN914249
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported issue: during use on a patient, the balloon burst.The surgeon recovered all the parts of the balloon from the abdomen.
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.The device history review weckvista access balloon port 12mmx70mm lot# 73j2200215 investigation did not show issues related to complaint.Teleflex will continue to monitor and trend related events.

• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16437391
• Report Number: 3003898360-2023-00227
• Device Sequence Number: 7447970
• Product Code: GCJ
• UDI-Device Identifier: 14026704645227
• UDI-Public: 14026704645227
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 01/27/2023

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: 09/05/2024
• Device Model Number: IPN914249
• Device Catalogue Number: 412944
• Device Lot Number: 73J2200215
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED
• Patient Sex: Unknown