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

Model Number 720185-01

Device Problems Mechanical Problem (1384); Migration (4003)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Urinary Retention (2119); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 06/15/2021

Event Type  Injury  

Manufacturer Narrative

Pending investigation.

Event Description

It was reported that the patient presented to the hospital complaining about urinary retention, pain, swelling and penile purulent drainage.The physician diagnosed that the inflatable penile prosthesis (ipp) was infected.The patient underwent an ipp explant procedure.It was observed that one of the cylinders extruded and migrated through the meatus.The explanted device was not working.The patient developed sepsis and required antibiotic treatment for 7 days following the surgical intervention.

Manufacturer Narrative

Investigation summary: with all the available information, boston scientific concludes as no further information regarding this event is expected, our investigation is complete.This report will be updated should additional information be provided.Device history record review: the device history record (dhr) confirmed that the device met all material, assembly, and performance specifications.Device technical analysis: upon receipt at our post market quality assurance laboratory, this ipp was thoroughly analyzed.The momentary squeeze (ms) pump, the flat reservoir and both cylinders were returned.The ms pump was visually inspected, and no visual defect was noted; however, the pump did not pass the activation test.The reservoir was visually inspected, microscopically examined and tested for leaks; it passed all tests performed.The kink resistant tubing was noted to be worn; however, no leak was identified.The cylinders were visually inspected, microscopically examined and tested for leaks.It was observed that both cylinders presented folds in the proximal component body.Both cylinders passed all tests performed.Labeling review: there is no objective evidence that the user did not properly handle or use the device according to the ipp instructions for use (ifu).The ifu lists mechanical issue, migration, pain, tissue damage, swelling, purulent discharge, infections, and sepsis, as potential adverse events associated with implant of this device.Investigation conclusion: no further actions are considered necessary and the complaint investigation conclusion code is known inherent risk of device.

Event Description

It was reported that the patient presented to the hospital complaining about urinary retention, pain, swelling and penile purulent drainage.The physician diagnosed that the inflatable penile prosthesis (ipp) was infected.The patient underwent an ipp explant procedure.It was observed that one of the cylinders extruded and migrated through the meatus.The explanted device was not working.The patient developed sepsis and required antibiotic treatment for 7 days following the surgical intervention.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12435794
• MDR Text Key: 270215754
• Report Number: 2124215-2021-26870
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953005669
• UDI-Public: 00878953005669
• Combination Product (y/n): Y
• 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: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/20/2018
• Device Model Number: 720185-01
• Device Catalogue Number: 720185-01
• Device Lot Number: 0144627011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 115