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

Model Number	ESR9162400
Medical Device Problem Code	Fracture (1260)
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 explantation due to a tubing break.The break was at the pump.A malleable device was implanted.No other adverse patient effects were reported.
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.
Additional Manufacturer Narrative
Titan otr 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.The surfaces of the detachment site of the pump inlet tubing appears 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 neither cylinder 1 nor cylinder 2.A group of striations, indicating contact with unshod instrumentation, was noted on the reservoir strain relief.This is not a site of leakage.A separation was noted on the reservoir inlet tube near the strain relief junction].This is a site of leakage.The surfaces appear to be rough and irregular, indicating stress was exerted.Based on examination of the returned product, it was concluded that while in-vivo both the exhaust tubes and inlet tube of the pump had overlapped and abraded against one another.The rough and irregular surfaces associated with the detachment ends of pump and reservoir indicates that sufficient stress(s) may have been exerted on the inlet tubing to separate the site while in-vivo.The rough and irregular surfaces associated with the separation in the reservoir inlet tube near the strain relief indicates sufficient stress may also have been exerted to separate the site 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 all sites were the cause for the reported 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 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; 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: 15316696
• Report Number: 2125050-2022-00837
• Device Sequence Number: 14753208
• Product Code: FHW
• UDI-Device Identifier: 05708932487641
• UDI-Public: 05708932487641
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/07/2022

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: ESR9162400
• Device Catalogue Number: ESR916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 11/07/2022
• 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: 52 YR
• Patient Sex: Male