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

Model Number	720182-01
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient underwent surgical intervention to replace an inflatable penile prosthesis (ipp) due to a hole in the reservoir that resulted in the device not working.A new ipp reservoir was implanted.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt of the inflatable penile prosthesis (ipp) at our quality assurance laboratory, the returned components underwent a thorough analysis.Both cylinders were inspected.One of the cylinders had air between the inner and outer fabric layers and the tube bulged when it was inflated.Examination of the pump found no leaks, but the pump spring was misaligned.The pump did not pass the activation testing that was performed.The reservoir component did not present any leaks and passes functional testing within product specifications.Based on the information available and analysis results, the reported event was unable to be confirmed.Due to the cylinder bulging, pump misalignment, and pump not performing within product specifications, the conclusion of cause traced to component failure was chosen.
Event or Problem Description
It was reported that the patient underwent surgical intervention to replace an inflatable penile prosthesis (ipp) due to a hole in the reservoir that resulted in the device not working.A new ipp reservoir was implanted.There were no patient complications reported.

• 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
• MDR Report Key: 15971576
• Report Number: 2124215-2022-51396
• Device Sequence Number: 6442820
• Product Code: FHW
• UDI-Device Identifier: 00878953005676
• UDI-Public: 00878953005676
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2023

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: 10/26/2021
• Device Model Number: 720182-01
• Device Catalogue Number: 720182-01
• Device Lot Number: 0154540011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2016
• 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: PUMP: LOT#: 164380002; PUMP: LOT#: 164380002
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male