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

Model Number	72404300
Medical Device Problem Codes	Collapse (1099); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: based on the information available, the cause that contributed to the reported pump mechanical issues cannot be established as the product is not available for analysis.Dhr review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient indicated the inflatable penile prosthesis (ipp) pump felt very hard after working normally for the first three months.During an appointment with the physician, the pump inflated the first time it was tested; however, on subsequent attempts the pump would remain collapsed.Troubleshooting was attempted to no avail by following the instructions on the operating room manual.A surgical procedure was scheduled for (b)(6) 2021 but was rescheduled to an unknown date as the facility awaited confirmation if the replacement was authorized.There were no patient complications associated to the event.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes that product analysis was unable to confirm the reported events of pump dimpling and mechanical issues.Dhr review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Technical analysis: upon receipt at our post market quality assurance laboratory, this ams 700 was thoroughly analyzed.The pump was visually and microscopically inspected, revealing no damages.The pump passed all the functional testing performed.Visual and microscopical inspection of the cylinders revealed a hole in the outer tube of cylinder 1.This hole was consistent with sharp instrument damage from explant.Cylinder 1 could not be pressure tested due to the leak identified.Cylinder 2 passed all tests performed.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion: based on the information available, a conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that the patient indicated the inflatable penile prosthesis (ipp) pump felt very hard after working normally for the first three months.During an appointment with the physician, the pump inflated the first time it was tested; however, on subsequent attempts the pump would remain collapsed.Troubleshooting was attempted to no avail by following the instructions on the operating room manual.A replacement surgery was performed in which the existing device was removed and a new ipp was implanted.There were no patient complications associated to the event.

• 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
• MDR Report Key: 12075273
• Report Number: 2124215-2021-17683
• Device Sequence Number: 19861333
• Product Code: FHW
• UDI-Device Identifier: 00878953005713
• UDI-Public: 00878953005713
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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: 06/01/2022
• Device Model Number: 72404300
• Device Catalogue Number: 72404300
• Device Lot Number: 0176259003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Initial Date Received by Manufacturer: 06/05/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR: 720182-01/1000429173
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR