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

Model Number	EN29112400
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
The lot # 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.
Event or Problem Description
According to available information, this device was explanted and replaced due to a fracture of the tubing near the cylinder.No other adverse patient effects were reported.
Event or Problem Description
According to the available information the titan touch was implanted on (b)(6) 2018 and revised on (b)(6) 2021 due to a fracture in the tubing near the cylinder.During the explant procedure, the device tubing was cut inadvertently.
Additional Manufacturer Narrative
Titan touch pump, cylinders 1 and 2, reservoir, and detached inlet tube with connector were received for evaluation.Abrasion was noted on all tubes of the pump.No functional abnormalities were noted with the pump.A separation was noted in the exhaust tube of cylinder 2 at the tube/strain relief junction.This was a site of leakage.The surfaces appeared to be rough and irregular, indicating stress was exerted.Abrasion was noted on the exhaust tube of cylinder 2.No functional abnormalities were noted with cylinder 1.No functional abnormalities were noted with the reservoir.Partial separations within abrasion were noted on the detached inlet tube.This was not a site of leakage.Based on examination of the returned product, it was concluded that while in-vivo all pump tubes had overlapped and abraded against one another.This positioning, in combination with device usage over time, may contribute to sufficient stress(s) on the exhaust tube of cylinder 2 near the tube/strain relief junction to separate the tubing.A separation of this type could then allow the loss of fluid, making the device inoperable.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 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: 12433945
• Report Number: 2125050-2021-01267
• Device Sequence Number: 14331749
• Product Code: FHW
• UDI-Device Identifier: 05708932539081
• UDI-Public: 05708932539081
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• 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): 11/09/2021

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: EN29112400
• Device Catalogue Number: EN2911
• Device Lot Number: 4062299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 10/16/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 11/09/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male