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

Model Number ES29181022

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Type  Injury  

Event Description

According to available information, this device required replacement due to fluid loss.A lack of fluid in the device was seen on a diagnostic ultrasound.A crack in the tubing was identified during surgery.No other adverse patient effects were reported.

Manufacturer Narrative

The lot number 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.

Manufacturer Narrative

Titan touch pump and cylinders 2 were received for evaluation.Abrasion was noted on both exhaust tubes and the inlet tube of the pump.A separation was noted on the longer exhaust tube of the pump near the strain relief junction.This is a site of leakage.The surfaces appear to be rough and irregular, indicating stress was exerted.A separation, surrounded by abrasion, was noted on the shorter exhaust tube of the pump.This is a site of leakage.See attached photo.A failure of the back pressure test was noted with the pump as the balls in the pump failed to seat properly.It was determined that foreign material was noted in the spring/ball and seat component of the pump.No functional abnormalities were noted with cylinder 2.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.This positioning, in combination with device usage over time, could contribute to sufficient stress to separate the shorter exhaust tubing.The rough and irregular surfaces associated with the separation indicates that sufficient stress was exerted on the longer exhaust tube near the pump 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.Review of the returned pump was conducted.During this review, it was concluded that the foreign material noted in the spring/ball and seat component of the pump resulted in the failure of the back pressure testing.Because these components were released according to manufacturing and quality control procedures, it was concluded that the foreign material observed most likely entered the system after the device packaging was opened.Failure of this test was not associated with the cause of the reported device malfunction.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
• 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: 15704255
• MDR Text Key: 302760268
• Report Number: 2125050-2022-01177
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/26/2022
• Device Model Number: ES29181022
• Device Catalogue Number: ES2918
• Device Lot Number: 5533060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2017
• 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: 31 YR