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

Model Number ES29222400

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

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

Event Type  Injury  

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.

Event Description

According to available information, this device required replacement due to a fluid leak.It was noted that there was no fluid in the system and also a crack was in the left hand side tubing.The original reservoir was left in situ and capped with a true-lock plug.No other adverse patient effects were reported.

Manufacturer Narrative

Additional review determined that this event was also reported under manufacturer report number: 2125050-2022-00410; the duplicate complaint records have now been merged and any additional information received will be submitted under this manufacturer report number: 2125050-2022-00368.A titan touch pump, two cylinders, and detached inlet tubing were received for analysis.Abrasion was noted on both exhaust tubes and the inlet tube of the pump.A separation, surrounded by abrasion, was noted on the shorter exhaust tube of the pump at the strain relief junction.This was a site of leakage.The surfaces appear to be rough and irregular, indicating stress was exerted.A group of striations, indicating contact with unshod instrumentation, was noted on the exhaust tube of cylinder 1.This was a site of leakage.A separation was noted on the bladder of cylinder 2.This was a site of leakage.The separation had surfaces with a darkened or melted appearance, indicating contact with a cauterizing tool.A group of striations, indicating contact with unshod instrumentation, was noted on the detached inlet tubing.This was a site of leakage.Another group of striations, indicating contact with unshod instrumentation, was also noted on the detached inlet tubing at a separate location.This was not a site of leakage.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 near the strain relief.A separation of this type could then allow the loss of fluid, making the device inoperable.Because these components were released according to manufacturing and quality control procedures, it was concluded that the observed instrument separations in the exhaust tubing of cylinder 1, bladder of cylinder 2, and on the piece of detached inlet tubing all occurred after the device packaging was opened.In addition, because the expected use of this device combined with the observed separations would have resulted in an earlier detected fluid loss, it was concluded that the separations most likely occurred during or after explant.These separations are not associated with the cause for failure.

• 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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 14052150
• MDR Text Key: 288860964
• Report Number: 2125050-2022-00368
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539203
• UDI-Public: 05708932539203
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/06/2019
• Device Model Number: ES29222400
• Device Catalogue Number: ES2922
• Device Lot Number: 4047914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2014
• 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: 76 YR
• Patient Sex: Male