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

Model Number	QN89161400
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.Once our evaluation is complete, a follow-up report will be submitted.
Event or Problem Description
According to available information, this device was explanted due to a leak in the tubing near the pump.A new device was successfully implanted and no other adverse patient effects were reported.
Additional Manufacturer Narrative
Lot number: 5258471.A titan pump, two cylinders, and a reservoir were received for analysis.Microscopic evaluation revealed surface abrasion on the pump inlet tubing, indicating repetitive contact between surfaces.Microscopic evaluation revealed the detachment end of the pump exhaust strain relief at the strain relief/pump body junction was rough and irregular, indicating sufficient stress was exerted to separate the site.A partial separation was noted through the strain relief of the longer pump exhaust tube.This was not a site of leakage.No functional abnormalities were noted with the pump.Microscopic evaluation revealed surface abrasion on the cylinder 2 exhaust tubing adjacent to the distal tubing /strain relief junction.Microscopic evaluation revealed the detachment end of the cylinder 2 strain relief was noted to be rough and irregular.No functional abnormalities were noted with cylinder 1 or cylinder 2.No functional abnormalities were noted with the reservoir.Based on examination of the returned product, the surface abrasion noted on the pump inlet tubing and the pump exhaust tubing attached to cylinder 2, matched in such a way to conclude that they had overlapped and abraded against one another while in-vivo.In addition, the rough surfaces of the detachment site through the strain relief of the pump exhaust tube indicated that sufficient stress(s) may have been exerted to separate the site while in-vivo.A separation of this type may then allow the loss of fluid, rendering the device inoperable.A review of the device history record confirmed that the devices from this lot met all specifications prior to release.A review of the complaint history database, non-conformances 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: 11841121
• Report Number: 2125050-2021-00542
• Device Sequence Number: 4689117
• Product Code: FHW
• UDI-Device Identifier: 05708932323604
• UDI-Public: 05708932323604
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/20/2021

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: QN89161400
• Device Catalogue Number: QN8916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 09/20/2021
• 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: 53 YR