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

Model Number QSR9201400

Device Problems Fluid/Blood Leak (1250); Appropriate Term/Code Not Available (3191); Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2022

Event Type  Injury  

Event Description

According to available information, this device was explanted and replaced due to an unspecified malfunction.No other adverse patient effects were reported.

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.The lot number (2071230) was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

Event Description

Additional information received further reported the implant began to fail as there was most likely a leak in the system, with air in the pump.The device was replaced with another manufacturer's product.

Manufacturer Narrative

Titan otr pump, cylinders 1 and 2, and reservoir were received for evaluation.The surfaces of the detachment site of the exhaust tube of the pump appear to be rough and irregular, indicating stress was exerted.The surfaces of the detachment site of the exhaust tube of cylinder 1 appear to be rough and irregular, indicating stress was exerted.Partial separations, surrounded by abrasion, were noted on the exhaust tube of cylinder 1.These were not sites of leakage.No functional abnormalities were noted with cylinder 2.No functional abnormalities were noted with the reservoir.Based on examination of the returned product, while no functional abnormalities were noted during testing with the returned components, microscopic examination of the surfaces of the exhaust tube detachment end between the pump and cylinder 1 revealed rough and irregular surfaces, indicating stress was exerted.The stress exerted could have been sufficient to separate the exhaust tubing of the pump.A separation of this type would 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 OTR
• Type of Device: 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: 14801536
• MDR Text Key: 294676187
• Report Number: 2125050-2022-00645
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: QSR9201400
• Device Catalogue Number: QSR920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male