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

Model Number 72404273

Device Problem Collapse (1099)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 11/26/2019

Event Type  Injury  

Manufacturer Narrative

Medical device: model number: 72404310, lot number: 1000154062, model description: pump ms.

Event Description

It was reported that the right cylinder and pump of an inflatable penile prosthesis (ipp) device were explanted due to a "bent penis and dimple pump." a new pump and cylinder on the right side were implanted.Additional information received states the device issues began two weeks prior to surgery.No further details regarding the dimpled pump were provided.The physician does not believe there was any relationship between the penis bending to the right and the device.The physician believes this is a patient anatomy issue.The patient got well following the surgery.

Manufacturer Narrative

Device evaluation: the ams700 ipp cylinder was visually inspected and functionally tested; no leaks were found.The cylinder performed within specification.Device analysis was unable to confirm a device malfunction nor the reported allegation of a "non-straight" penis.The ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.The pump was functionally tested and found to fail the deflation test (3).A device malfunction was therefore confirmed.D4: model number: 72404310 lot number: 1000154062 model description: pump ms.

Event Description

It was reported that the right cylinder and pump of an inflatable penile prosthesis (ipp) device were explanted due to a "bent penis and dimple pump." a new pump and cylinder on the right side were implanted.Additional information received states the device issues began two weeks prior to surgery.No further details regarding the dimpled pump were provided.The physician does not believe there was any relationship between the penis bending to the right and the device.The physician believes this is a patient anatomy issue.The patient got well following the surgery.

• 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: 9498010
• MDR Text Key: 172092683
• Report Number: 2183959-2019-68266
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003801
• UDI-Public: 00878953003801
• 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: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/12/2023
• Device Model Number: 72404273
• Device Catalogue Number: 72404273
• Device Lot Number: 1000047352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Date Manufacturer Received: 01/14/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR