MAUDE Adverse Event Report: COLOPLAST A/S TITAN OTR INFRA 14CM; INFLATABLE PENILE PROSTHESIS

Model Number QSR8141022

Device Problems Inflation Problem (1310); Free or Unrestricted Flow (2945)

Patient Problem No Information (3190)

Event Date 05/08/2018

Event Type  Injury  

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 Description

According to the available information, the patient was admitted on (b)(6) 2018 for penile prosthesis implantation, returned on (b)(6) 2018 for withdrawal of due to the phenomenon of self-insufflation, complicating extortion of one of the cylinders by the urethra.

Manufacturer Narrative

This follow-up mdr is created to document the updated conclusion of the investigation.A titan otr pump, two cylinders and a reservoir were received for evaluation.Examination and testing of the returned components revealed separations in the longer pump exhaust tube and the reservoir inlet tube.The separations appear to be within a group of striations, indicating contact with unshod instrumentation.Partial separations were noted in the shorter exhaust tube of the pump.Testing revealed these not to be sites of leakage.The separations appear to be within a group of striations, indicating contact with unshod instrumentation.The detachment sites of the pump and cylinder exhaust tubes appeared rough and irregular, indicating sufficient stress(s) was exerted to separate the sites.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Review of nonconforming reports revealed no nonconformance with this lot that would have contributed to the event.A review of the complaint database revealed no significant trends in complaints of this type for lot 4674376.The information received indicated auto-inflation, but because no visual or functional abnormalities were noted with the returned components other than instrument damage, quality is unable to confirm the reported complaint.Because these components were released according to manufacturing and quality control procedures, quality concluded that the rough and irregular surfaces associated with the detachment sites of the pump and cylinder exhaust tubes occurred subsequent to the device packaging being opened.In addition, because the expected use of this device combined with the observed separation would have resulted in an earlier detected fluid loss, quality concluded that the separation most likely occurred during or after explant.This separation is not associated with the cause for failure.Because quality's examination of the returned components may not conclusively confirm or disprove the report of "extrusion of one of the cylinders by the urethra" and "venous injury (due to the adhesion of the reservoir to the left iliac vein)", quality accepts the physician's observations of such as the reason for surgical intervention.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information no further corrective action is required at this time.

Manufacturer Narrative

A titan otr pump, two cylinders and a reservoir were received for evaluation.Examination and testing of the returned components revealed separations in the longer pump exhaust tube and the reservoir inlet tube.The separations appear to be within a group of striations, indicating contact with unshod instrumentation.Partial separations were noted in the shorter exhaust tube of the pump.Testing revealed these not to be sites of leakage.The separations appear to be within a group of striations, indicating contact with unshod instrumentation.The detachment sites of the pump and cylinder exhaust tubes appeared rough and irregular, indicating sufficient stress(s) was exerted to separate the sites.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Review of nonconforming reports revealed no nonconformance with this lot that would have contributed to the event.A review of the complaint database revealed no significant trends in complaints of this type for lot 4674376.The information received indicated auto-inflation, but because no visual or functional abnormalities were noted with the returned components other than instrument damage, quality is unable to confirm the reported complaint.Because these components were released according to manufacturing and quality control procedures, quality concluded that the rough and irregular surfaces associated with the detachment sites of the pump and cylinder exhaust tubes occurred subsequent to the device packaging being opened.In addition, because the expected use of this device combined with the observed separation would have resulted in an earlier detected fluid loss, quality concluded that the separation most likely occurred during or after explant.This separation is not associated with the cause for failure.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information no further corrective action is required at this time.

Event Description

Additional information received indicated extrusion of one of the cylinders by the urethra.Additional information received on 09/18/2018 indicated the patient was submitted to the removal of an inflatable penile prosthesis and correction of venous injury (due to the adhesion of the reservoir to the left iliac vein) is undergoing an outpatient clinic with clinical improvement, awaiting the implantation of a new prosthesis.

• Brand Name: TITAN OTR INFRA 14CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7748483
• MDR Text Key: 115972570
• Report Number: 2125050-2018-00569
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2018

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: QSR8141022
• Device Catalogue Number: QSR814
• Device Lot Number: 4674376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/03/2018
• Supplement Dates Manufacturer Received: 07/12/2018; 07/12/2018
• Supplement Dates FDA Received: 09/24/2018; 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other