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

Model Number	72404303
Medical Device Problem Codes	Failure to Cycle (1142); Material Discolored (1170); Inflation Problem (1310); Malposition of Device (2616)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104); Discomfort (2330)
Date of Event	03/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient is experiencing pain at the base of the penis and spontaneous insufflation of the prosthesis after completely emptying the cylinders with an inflatable penile prosthesis (ipp).The ipp remains implanted and active.Magnetic resonance imaging was completed, a caliber difference between the cylinder in the distal portion was observed.An ultrasound found a reduction in the ipsilateral caliper.
Additional Manufacturer Narrative
Correction: b1, b2.
Event or Problem Description
It was reported that the patient is experiencing pain at the base of the penis and spontaneous insufflation of the prosthesis after completely emptying the cylinders with an inflatable penile prosthesis (ipp).The ipp remains implanted and active.Magnetic resonance imaging was completed, a caliber difference between the cylinder in the distal portion was observed.An ultrasound found a reduction in the ipsilateral caliper.
Event or Problem Description
It was reported that the patient is experiencing pain and discomfort at the base of the penis and spontaneous insufflation of the prosthesis after completely emptying the cylinders with an inflatable penile prosthesis (ipp).The ipp remains implanted and active.Magnetic resonance imaging was completed, a caliber difference between the cylinder in the distal portion was observed.An ultrasound found a reduction in the ipsilateral caliper.The patient followed-up with the physician on (b)(6) 2020.The physician completed another mri and observed bulging of the left cylinder, that was suggestive of prosthetic aneurysm, as a result there was compression of the white tunica and consequent thinning of the wall.The bulging of the cylinder are causing discomfort and the physician has requested to revise the device.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9944028
• Report Number: 2183959-2020-01956
• Device Sequence Number: 13893822
• Product Code: FHW
• UDI-Device Identifier: 00878953005744
• UDI-Public: 00878953005744
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/29/2023
• Device Model Number: 72404303
• Device Catalogue Number: 72404303
• Device Lot Number: 1000109518
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 04/20/2020; 12/15/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 04/20/2020; 01/04/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR