MAUDE Adverse Event Report: TELEFLEX MEDICAL WECKVISTA ACCESS BALLOON PORT 10MMX70MM; LAPAROSCOPE, GENERAL & PLASTIC

Model Number	IPN914248
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that during use at the beginning of the procedure, the balloon burst.As a result, a 2nd balloon was used which burst as well.A 3rd balloon was used with no issues.An x-ray was used to visualize the broken pieces, all were removed from the patient.No patient harm or injury.The patient status is reported as "fine".See associated mdr 3003898360-2023-00728.
Event or Problem Description
It was reported that during use at the beginning of the procedure, the balloon burst.As a result, a 2nd balloon was used which burst as well.A 3rd balloon was used with no issues.An x-ray was used to visualize the broken pieces, all were removed from the patient.No patient harm or injury.The patient status is reported as "fine".See associated mdr 3003898360-2023-00728.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one unit 410944 weckvista access balloon port 10mmx70mm for investigation.The returned sample was examined with and without magnification.Visual examination of the returned sample revealed that the balloon was partially detached from the cannula at the proximal end.The observed damage indicates that the balloon was over-inflated.The sample appears used as there is biological material present on the device.Functional inspection could not be performed based on the condition of the sample received.A device history record review was performed and no relevant findings were identified.The ifu for this product 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 reported complaint was confirmed based upon the sample received.The device was returned with the balloon partially separated from the cannula at the proximal end.This damage is consistent with damage found when the balloon has been over-inflated.All balloon ports are 100% inspected for inflation during the inspection process.Based upon the damage observed, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: WECKVISTA ACCESS BALLOON PORT 10MMX70MM
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16940889
• Report Number: 3003898360-2023-00729
• Device Sequence Number: 7451875
• Product Code: GCJ
• UDI-Device Identifier: 04026704559756
• UDI-Public: 04026704559756
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/24/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2024
• Device Model Number: IPN914248
• Device Catalogue Number: 410944
• Device Lot Number: 73D2200374
• 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: 04/24/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2022
• 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