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

Model Number	ES28142400
Medical Device Problem Code	Fracture (1260)
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.Device not returned.
Event or Problem Description
As reported to coloplast, though not verified, tubing fracture.Device was explanted and replaced.No other adverse patient effects were reported.
Additional Manufacturer Narrative
Titan touch pump, and cylinders 1 and 2 were received for evaluation.Abrasion was noted on both exhaust tubes and the inlet tubing of the pump.No functional abnormalities were noted with the pump.The detachment end of the inlet tube appeared rough and irregular, indicating stress was exerted, along with pulled monofilament.Abrasion was noted on the exhaust tubing of cylinder 1, near the detachment site from the pump.A separation was noted on the exhaust tubing of cylinder 1.This is a site of leakage.The surfaces appear to be rough and irregular, indicating stress was exerted.Partial separations were noted on the exhaust tube of cylinder 1.These were not sites of leakage.A separation was noted in the exhaust tubing of cylinder 2 at the strain relief junction.This was a site of leakage.The surfaces appear to be rough and irregular, indicating stress was exerted.Two separations were noted on the bladder of cylinder 2.These were sites of leakage.The separations had a central groove, indicating contact with sharp instrumentation such as a needle.Based on examination of the returned product, while in-vivo the pump tubing had overlapped and abraded against one another.This positioning, in combination with device usage over time, resulted in rough and irregular surfaces indicating that sufficient stress(s) may have been exerted on the exhaust tube of cylinder 1, and the exhaust tube of cylinder 2 near the strain relief junction to separate the sites while in-vivo.Separations of this type could then allow the loss of fluid, making the device inoperable.However, as additional information was not received, it could not be determined if one or both sites were the cause for the reported failure.Because these components were released according to manufacturing and quality control procedures, and assumed functional for approximately four years, it was concluded that the observed instrument separations in the bladder of cylinder 2 occurred after the device packaging was opened.In addition, because the expected use of this device combined with the observed separations would have resulted in an earlier detected fluid loss, it was concluded that the separation most likely occurred during or after explant.These separations are not associated with the cause for failure.In addition, due to the amount of monofilament pulled out at the pump inlet tube detachment end, it was concluded this most likely occurred during explant and not cause for failure.D4 lot: 4348672.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.
Event or Problem Description
According to the available information this inflatable penile prosthesis was implanted on (b)(6) 2017 and revised on (b)(6) 2021 due to a tubing fracture.

• Brand Name: TITAN TOUCH
• 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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12801681
• Report Number: 2125050-2021-01651
• Device Sequence Number: 20028100
• Product Code: FHW
• UDI-Device Identifier: 05708932539104
• UDI-Public: 05708932539104
• Combination Product (Y/N): N
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2022

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: ES28142400
• Device Catalogue Number: ES2814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 01/17/2022
• 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: 55 YR
• Patient Sex: Male