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

Model Number	72404280
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Codes	Erosion (1750); Inflammation (1932); Pain (1994)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced severe pain and redness at the incision site and was not able to inflate or deflate the inflatable penile prosthesis.A cystoscopy found extrusion of the device through the urethra.The patient was expected to undergo a revision surgery.No further patient complications were reported.
Event or Problem Description
It was reported that the patient experienced severe pain and redness at the incision site and was not able to inflate or deflate the inflatable penile prosthesis(ipp).A cystoscopy found extrusion through the urethra.The patient had the ipp explanted.Following the procedure, the patient was ok and there were no further patient complications.
Event or Problem Description
It was reported that the patient experienced severe pain and redness at the incision site and was not able to inflate or deflate the inflatable penile prosthesis(ipp).A cystoscopy found extrusion through the urethra.The patient had the ipp explanted.Following the procedure, the patient was ok and there were no further patient complications.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The ams700 ipp spherical reservoir was visually inspected, leak tested and examined using a microscope.There was a hole in the surface of the kink resistant tubing (krt) that was the result of sharp instrument damage which probably occurred during the explant surgery.The hole did not go through to the inside; therefore, the reservoir passed the leak test that was performed.Product analysis was unable to identify device malfunction with the returned reservoir.The ams 700 ipp cylinders were visually inspected, leak tested, pressure tested and examined using a microscope.No leaks were found, and they passed the pressure test therefore, the cylinders performed within specification.The ams 700 momentary squeeze (ms) pump was visually inspected, leak tested and examined using a microscope.No leaks and no misalignment were found.The pump was functionally tested and did not pass the inflation test, which could affect the deflation function of the system.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 14214675
• Report Number: 2124215-2022-13381
• Device Sequence Number: 14495830
• Product Code: FHW
• UDI-Device Identifier: 00878953003832
• UDI-Public: 00878953003832
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2022

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: 12/10/2021
• Device Model Number: 72404280
• Device Catalogue Number: 72404280
• Device Lot Number: 0156868005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 05/18/2022; 07/21/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 06/08/2022; 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR MODEL# 72404161 LOT NO. 1000188521; RESERVOIR MODEL# 72404161 LOT NO. 1000188521; RESERVOIR MODEL# 72404161 LOT NO. 1000188521
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male