MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

Model Number 72404013

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Complaint, Ill-Defined (2331)

Event Date 07/11/2019

Event Type  Injury  

Event Description

It was reported that the left cylinder of the inflatable penile prosthesis (ipp) was explanted due to "urethra bleeding." the right cylinder, pump and reservoir were previously removed on (b)(6) 2019.Additional information received that the friction between the cylinder and the wall of the urethra caused the bleeding.The patient outcome was reported to be well.Product was explanted and expected to be returned.A supplemental report will be filed after product has been returned and product analysis has been completed.

Event Description

It was reported that the left cylinder of the inflatable penile prosthesis (ipp) was explanted due to "urethra bleeding." the right cylinder, pump and reservoir were previously removed on (b)(6) 2019.Additional information received that the friction between the cylinder and the wall of the urethra caused the bleeding.The patient outcome was reported to be well.Product was explanted and expected to be returned.A supplemental report will be filed after product has been returned and product analysis has been completed.Additional information received states that urethral perforation was diagnosed.

Event Description

It was reported that the left cylinder of the inflatable penile prosthesis (ipp) was explanted due to "urethra bleeding." the right cylinder, pump and reservoir were previously removed on (b)(6) 2019.Additional information received that the friction between the cylinder and the wall of the urethra caused the bleeding.The patient outcome was reported to be well.Product was explanted and expected to be returned.A supplemental report will be filed after product has been returned and product analysis has been completed.Additional information received states that urethral perforation was diagnosed.

Manufacturer Narrative

Device analysis: urethral bleeding was reported.The ams700 cylinder was visually inspected and functionally tested.No leak was found.It performed within specifications.No device issue or malfunction could be confirmed.The investigation conclusion code of known inherent risk of the device was chosen because the reported adverse events are known and documented in the labelling.Based on the results of this investigation, no escalation is required.If further information is received at a later date, the product investigation will be reopened to address the additional information.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8856924
• MDR Text Key: 153147220
• Report Number: 2183959-2019-65473
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953002705
• UDI-Public: 00878953002705
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/18/2022
• Device Model Number: 72404013
• Device Catalogue Number: 72404013
• Device Lot Number: 0176264005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Date Manufacturer Received: 09/30/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR