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

Model Number 72404257

Device Problems Deflation Problem (1149); Inflation Problem (1310); Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2020

Event Type  Injury  

Event Description

It was reported that the patient could not inflate or deflate his inflatable penile prosthesis (ipp) pump because of where it was initially placed in his scrotum.Patient's cylinders were also undersized.Pump and cylinders were removed and replaced.The patient had a good outcome.

Manufacturer Narrative

The complaint component was returned and analyzed, and the reported allegation was not confirmed via product analysis.The ams700 ipp cylinders were visually inspected and functionally tested; no leaks were found.Both cylinders performed within specification.The ams 700 momentary squeeze (ms) pump was visually inspected and functionally tested.No leaks were found.Pump was functional tested and performed within specification.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.

Event Description

It was reported that the patient could not inflate or deflate his inflatable penile prosthesis (ipp) pump because of where it was initially placed in his scrotum.Patient's cylinders were also undersized.Pump and cylinders were removed and replaced.The patient had a good outcome.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 10263604
• MDR Text Key: 198503840
• Report Number: 2183959-2020-02890
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003658
• UDI-Public: 00878953003658
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

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 Expiration Date: 12/09/2021
• Device Model Number: 72404257
• Device Catalogue Number: 72404257
• Device Lot Number: 1000367253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 07/28/2020
• Supplement Dates FDA Received: 08/18/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR