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

Model Number 72404301

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problems Internal Organ Perforation (1987); Pain (1994); Perforation (2001)

Event Date 08/16/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced a removal of a preconnect inflatable penile prosthesis(ipp) implant due to the patient experiencing severe pain after surgery.The device malfunctioned due to corporal perforation.The customer reports that one cylinder was buckled and the pump had fluid loss.The surgeon removed the preconnect component and repaired the urethra and corpora.A new device will be implanted in six months.

Manufacturer Narrative

Device malfunction, pain, and perforation were reported.The ams700 device was visually inspected and functionally tested.The cylinders performed within specifications.The pump failed the inflation test and did not transfer a sufficient amount of fluid to fully inflate the cylinders.The analysis confirms the allegation of device malfunction, as an inability by the pump to transfer a sufficient amount of fluid to the cylinders could appear to a user to be a loss of fluid in the pump.Pain and perforation could not be confirmed through product analysis.The investigation conclusion code of cause traced to component failure was chosen because the device complaint was traced to a component failure during product analysis.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.

Event Description

It was reported that the patient experienced a removal of a preconnect inflatable penile prosthesis(ipp) implant due to the patient experiencing severe pain after surgery.The device malfunctioned due to corporal perforation.The customer reports that one cylinder was buckled and the pump had fluid loss.The surgeon removed the preconnect component and repaired the urethra and corpora.A new device will be implanted in six months.

• 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: 8982980
• MDR Text Key: 157145002
• Report Number: 2183959-2019-66099
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953005720
• UDI-Public: 00878953005720
• 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
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/18/2022
• Device Model Number: 72404301
• Device Catalogue Number: 72404301
• Device Lot Number: 0181822003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 10/08/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 56 YR