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

Model Number	ES89162400
Medical Device Problem Code	Mechanical Problem (1384)
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 explanted and replaced due to an unspecified mechanical malfunction.No other adverse patient effects were reported.
Additional Manufacturer Narrative
A titan pump, cylinder 1 and reservoir were received for evaluation.A separation was noted in the pump body.This was a site of leakage.Microscopic examination of the surfaces appeared to be rough and irregular, indicating stress was exerted.Partial separations within abrasion were noted on the longer exhaust tube and inlet tube of the pump.These are not sites of leakage.Abrasion was also noted on the shorter exhaust tube and other area of the inlet tube of the pump.No functional abnormalities were noted with cylinder 1.Separations within abrasion were noted on the inlet tube of the reservoir.This was a site of leakage.Partial separations within abrasion were also noted on the inlet tube of the reservoir.Based on examination of the returned product, it was concluded that while in-vivo all pump tubes had overlapped and abraded against one another.The rough and irregular surfaces of the separation in the pump body indicated that sufficient stress(s) may have been exerted on the pump to separate the site while in-vivo.In addition, based on the abrasion noted on the reservoir inlet tube, this indicated that the tubing had abraded while in-vivo, resulting in the separation noted.Separations of these types 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
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11864446
• Report Number: 2125050-2021-00604
• Device Sequence Number: 4366782
• Product Code: FHW
• UDI-Device Identifier: 05708932487467
• UDI-Public: 05708932487467
• 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 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): 09/29/2021

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 Expiration Date: 05/16/2018
• Device Model Number: ES89162400
• Device Catalogue Number: ES8916
• Device Lot Number: 3714822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Initial Date Received by Manufacturer: 04/24/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR