MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE ECOBALLOON DIL-XL

Catalog Number	1285-60-11
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Irn# (b)(4) incident occurred in germany.Manufacturer awareness date of reportability: 2026-01-05.Precheck of complaint does not indicate any adverse conclusion.Investigations are ongoing.When new information becomes available an update will be sent to the agency.
Event or Problem Description
Irn#(b)(4) incident occurred in germany.Balloon burst - ruptured.
Event or Problem Description
Irn# (b)(4).Incident occurred in germany.Balloon burst - ruptured.
Additional Manufacturer Narrative
Irn# (b)(4).Incident occurred in germany.Manufacturer awareness date of reportability: 2026-01-05.Precheck of complaint does not indicate any adverse conclusion.Investigations are ongoing.When new information becomes available an update will be sent to the agency.Update 2026-02-16: update of investigation results and corresponding imdrf codes.This case is considered as closed.If further information becomes available an update will be send to the agency.

• Brand Name: ECOBALLOON DIL-XL
• Common Device Name: ECOBALLOON DIL-XL
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer Contact: armin pfeifer ; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• MDR Report Key: 24143698
• Report Number: 9611612-2026-00001
• Device Sequence Number: 13133421
• Product Code: GCJ
• UDI-Device Identifier: 04048223133026
• UDI-Public: 04048223133026
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K090631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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
• Device Catalogue Number: 1285-60-11
• Device Lot Number: 1600
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown