MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL RESIST 20; INFLATABLE PENILE PROSTHESIS

Model Number	QS89201000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/10/2019
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 proximal to the pump was found split in half.
Additional Manufacturer Narrative
This follow-up mdr is created to document the evaluation of the returned device, the additional event information, and the corrected device information.A titan pump, two cylinders, reservoir and two detached inlet tubes were received for evaluation.Examination and testing of the returned components revealed a separation within abrasion on the non-serialized exhaust tube of the pump.Testing revealed this to be a site of leakage.Partial separations within abrasion were noted on the non-serialized exhaust tube and inlet tube of the pump, as well as the exhaust tube of cylinder 1.Testing revealed these to not be sites of leakage.Microscopic examination of the detachment ends of the serialized exhaust tube and exhaust tube of cylinder 1 showed the surfaces to be rough and irregular, indicating stress was exerted.No functional abnormalities were noted with either cylinder, reservoir or either detached inlet tubing.Based on examination of the returned product, it was concluded that the abrasion marks noted on all tubing matched in such a way to conclude that they had overlapped and abraded against one another while in-vivo.This then most likely caused excess stress on the serialized exhaust tube to result a separation in the tubing.The information received indicated that the tubing was "split in half." in addition, with the tubing overlap and abrasion, this resulted in the separation noted on the non-serialized exhaust tube of the pump.Separations of these types 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.
Event or Problem Description
Additional information indicated this inflatable penile prosthesis was implanted approximately 10 ½ years ago and the pump tubing was found cut off about 2-3cm from the pump.

• Brand Name: TITAN SCROTAL RESIST 20
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8593122
• Report Number: 2125050-2019-00358
• Device Sequence Number: 16647840
• Product Code: FHW
• UDI-Device Identifier: 05708932487306
• UDI-Public: 05708932487306
• 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: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2019

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: QS89201000
• Device Catalogue Number: QS8920
• Device Lot Number: 0906684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 08/29/2019
• 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: 72 YR