MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 14CM; INFLATABLE PENILE PROSTHESIS

Model Number	ES29142400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received at coloplast; however the evaluation is not yet complete.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 the available information, the tubing fractured.The coil was completely hanging out of the tubing.
Additional Manufacturer Narrative
This follow-up mdr is created to document the conclusion of the evaluation.Three photos were received showing what appears to be part of an exhaust strain relief and exhaust tubing with a separation in-between them.A titan touch pump, two cylinders and detached inlet tubing were received for evaluation.Examination and testing revealed a separation within abrasion on the exhaust tube of cylinder 1.Testing revealed this to be a site of leakage.A group of separations, indicating contact with unshod instrumentation, was noted on the same exhaust tube of cylinder 1.Testing revealed this to be a site of leakage.A partial separation surrounded by abrasion was noted on the exhaust tube of cylinder 1.Testing revealed this to not be a site of leakage.Abrasion was also noted on all pump strain reliefs, exhaust tube of cylinder 2 and detached inlet tube.No functional abnormalities were noted with the pump, cylinder 2 or detached inlet tube.Based on examination of the returned product, it was concluded that while in-vivo all tubes of the pump had overlapped and abraded against one another.This positioning, in combination with device usage over time, could contribute to the exhaust tube of cylinder 1 abrading enough to cause a separation in the tubing.A separation of this type would then allow the loss of fluid, making the device inoperable.However, quality was unable to comment on the detached exhaust strain relief and tubing that was noted in the three pictures received.As that component was not returned for evaluation, quality was unable to complete a microscopic examination of the detachment surface ends to determine what may have contributed to the separation.Because these components were released according to manufacturing and quality control procedures, quality concluded that the observed instrument separation in the exhaust tube of cylinder 1 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 subsequent to explant.This separation is not associated with the cause for failure.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 SCRO ZERO ANG 14CM
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8670576
• Report Number: 2125050-2019-00458
• Device Sequence Number: 2130950
• Product Code: FHW
• UDI-Device Identifier: 05708932539166
• UDI-Public: 05708932539166
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: ES29142400
• Device Catalogue Number: ES2914
• Device Lot Number: 4047909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 10/10/2019
• 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: Other
• Patient Age: 80 YR