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

Model Number 72404310

Device Problem Collapse (1099)

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

Event Date 09/10/2019

Event Type  Injury  

Manufacturer Narrative

Device not returned for evaluation.

Event Description

It was reported that due to a dimpled pump the patient had his inflatable penile prosthesis (ipp) pump removed and replaced.It was further reported that when the patient pressed the pump, but it stayed flat.The device stopped working 3 weeks ahead of this surgery.The patient status after this surgery was that the patient got well.

Manufacturer Narrative

Pump malfunction was reported.The ams700 momentary squeeze pump was visually inspected and functionally tested.No leak was found.The pump failed the inflation test and did not transfer a sufficient amount of fluid to fully inflate the cylinders.The pump failed the 8 lb.Activation test.The pump required more than 8 lbs.Of force to activate.The product analysis confirmed the allegation of pump malfunction.Correction to g1, h2, h3, and h6: updated to include device analysis.

Event Description

It was reported that due to a dimpled pump the patient had his inflatable penile prosthesis (ipp) pump removed and replaced.It was further reported that when the patient pressed the pump, but it stayed flat.The device stopped working 3 weeks ahead of this surgery.The patient status after this surgery was that the patient got well.

• 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: 9125362
• MDR Text Key: 160233064
• Report Number: 2183959-2019-66403
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003986
• UDI-Public: 00878953003986
• 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: 10/21/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/11/2021
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 0135697005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 09/26/2019
• Supplement Dates Manufacturer Received: 10/21/2019
• Supplement Dates FDA Received: 10/21/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR