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

Model Number	ESR9222400
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
Event or Problem Description
As reported to coloplast, though not verified, patient's device was not inflating so it was explanted and replaced.No other adverse patient effects were reported.
Additional Manufacturer Narrative
Titan otr pump, and cylinders 1 and 2 were received for evaluation.No functional abnormalities were noted with the pump.A separation was noted on the exhaust tube of cylinder 2.This was a site of leakage.The surfaces of the separation appear to be rough and irregular, indicating stress was exerted.Abrasion was noted on the exhaust tube of cylinder 2.A separation was noted in the bladder of cylinder 1.This was a site of leakage.The surfaces of the separation appear to be smooth and straight, indicating contact with sharp instrumentation.An aneurysm was noted in the bladder of cylinder 2.This was not a site of leakage.Based on examination of the returned product, it was concluded that the rough and irregular surfaces associated with the separation in the exhaust tube of cylinder 2 indicates that sufficient stress(s) may have been exerted on this tube to separate the site while in-vivo.A separation of this type could then allow the loss of fluid, making the device inoperable.In addition, quality confirmed an aneurysm in the bladder of cylinder 2.An aneurysm may occur if excess pressure was exerted on the cylinder bladder.However, due to the information received, the device was revised as it was not inflating.Therefore, quality cannot confirm when the aneurysm may have occurred.Because these components were released according to manufacturing and quality control procedures, it was concluded that the observed instrument separation in the bladder of cylinder 1 occurred subsequent to the device packaging being 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 subsequent to 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.D4 lot: 3330538.
Event or Problem Description
According to the available information this inflatable penile prosthesis was implanted on (b)(6) 2012 and revised on (b)(6) 2021 due to the device was not inflating.

• Brand Name: TITAN OTR
• 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; 1940 commerce dr; north mankato
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12471084
• Report Number: 2125050-2021-01315
• Device Sequence Number: 4891853
• Product Code: FHW
• UDI-Device Identifier: 05708932487702
• UDI-Public: 05708932487702
• Combination Product (Y/N): N
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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 Model Number: ESR9222400
• Device Catalogue Number: ESR922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 70 YR
• Patient Sex: Male