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

Model Number	IPN914249
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Event or Problem Description
The balloon got broken during a surgery.Therefore, the device was replaced with a new one.Nothing fell/remained in the patient.
Event or Problem Description
The balloon got broken during a surgery.Therefore, the device was replaced with a new one.Nothing fell/remained in the patient.
Additional Manufacturer Narrative
(b)(4).Per dhr the product weckvista access balloon port 12mmx70mm lot # 73d2100390 was manufactured on 04/21/2021 a total of (b)(4) pieces.Lot was released on 06/10/2021.Dhr investigation did not show issues related to complaint.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 torn along the entire length from its proximal end to its distal end.The device cannula has scratch marks on both sides of the balloon that are in line with the tear on the balloon.Based on the observed damage, the device appears to have been scratched/scraped by a sharp object during use.Therefore, unintentional user error caused or contributed to this issue.The ifu for this product, l05459, 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.".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 "broken - balloon" was confirmed based upon the sample received.The balloon was torn along the entire length from its proximal end to its distal end.The device cannula has scratch marks on both sides of the balloon that are in line with the tear on the balloon.Based on the observed damage, the device appears to have been scratched/scraped by a sharp object during use.All balloon ports are 100% inspected for inflation during the inspection process.It is unlikely that this type of 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, 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 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13939262
• Report Number: 3003898360-2022-00119
• Device Sequence Number: 6432177
• Product Code: GCJ
• UDI-Device Identifier: 14026704645227
• UDI-Public: 14026704645227
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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: 04/12/2023
• Device Model Number: IPN914249
• Device Catalogue Number: 412944
• Device Lot Number: 73D2100390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• 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
• Patient Sex: Unknown