MAUDE Adverse Event Report: COLOPLAST A/S TITAN; INFLATABLE PENILE PROSTHESIS

Model Number	ES88162400
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to available information, this device required replacement due to not able to inflate.No other adverse patient effects were reported.
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Additional Manufacturer Narrative
Titan pump, cylinders 1 and 2, and reservoir were received for evaluation.Abrasion was noted on both exhaust tubes and the inlet tube of the pump.No functional abnormalities were noted with the pump.No functional abnormalities were noted with cylinder 1.Abrasion was noted on cylinder 2.A group of striations, indicating contact with unshod instrumentation, was noted on the exhaust tube of cylinder 2.This is not a site of leakage.A separation was noted on the bladder of cylinder 2.This is a site of leakage.The separation has a central groove, indicating contact with sharp instrumentation such as a needle.No functional abnormalities were noted with the reservoir.Based on examination, it was concluded that the observed separations in the cylinder 2 bladder would have allowed the reported inflation issue, however, because the limited information provided does not indicate any factors that may have contributed to the reported event, the sequence of events leading to the observed separation cannot be determined.Because these components were released according to manufacturing and quality control procedures, it was concluded that the observed unshod instrument separation in the exhaust tubing of cylinder 2 occurred after the device packaging was opened.In addition, because the expected use of this device combined with the observed separation would have resulted in an earlier detected fluid loss, it was concluded that the separation most likely occurred during or after explant.This separation is not associated with the cause for failure.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

• Brand Name: TITAN
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16268797
• Report Number: 2125050-2023-00094
• Device Sequence Number: 20451845
• Product Code: FHW
• UDI-Device Identifier: 05708932487184
• UDI-Public: 05708932487184
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2025
• Device Model Number: ES88162400
• Device Catalogue Number: ES8816
• Device Lot Number: 7685215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2020
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male