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

Model Number	72404291
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: based on the information available, the cause that contributed to the reported issue that the device did not work as expected due to a micro puncture in the cylinder, could not be established as the product is not available for analysis.Device technical analysis: the device was not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation of a micro puncture in the cylinder could not be confirmed.Investigation conclusion: based on this investigation a clear probable cause for the event cannot be established; therefore, the conclusion code of cause not established has been chosen.
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis removed due to a micro puncture in the cylinder.A new inflatable penile prosthesis consisting of cylinders, pump, and reservoir was implanted.Following the replacement surgery, the event resolved.
Additional Manufacturer Narrative
Investigation summary.With all the available information, boston scientific concludes, based on analysis results, the cause that contributed to the reported event of a micro puncture was unable to be confirmed.Device history record review (dhr): the device history record review (dhr) confirmed that the device met all material, assembly and performance specifications.A risk review confirmed that the event is accounted for in the risk documentation.Device technical analysis: upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The ams700 cylinders were visually inspected, leak tested and microscopically examined.Cylinder 1 had a large hole with broken fabric threads in the proximal cylinder body that was the result of a sharp instrument damage which probably occurred during the explant; a leak was present.Cylinder 2 had a leak in the cylinder body that was a result of sharp instrument damage; a hole was present that was consistent with explant damage.Both cylinders were not pressure tested due to the leaks identified.The ams700 momentary squeeze (ms) pump was leak tested, visually inspected and functionally tested; no visual damages were found upon inspection.The pump passed all tests performed.Product analysis was unable to identify device malfunction with the returned pump.Labeling review: a review of the device instructions for use (ifu) was completed and did not review any evidence of device off-label use or failure to follow instructions.Investigation conclusion: based on this investigation a clear probable cause for the event was not established; therefore, the investigation conclusion code cause not established was chosen because the cylinders were identified have sharp instrument damage that was consistent to explant damage.The most probable cause for the micro puncture could not be confirmed.
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis removed due to a micro puncture in the cylinder.A new inflatable penile prosthesis consisting of cylinders, pump, and reservoir was implanted.Following the replacement surgery, the event resolved.

• 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: 11946762
• Report Number: 2124215-2021-15796
• Device Sequence Number: 19103985
• Product Code: FHW
• UDI-Device Identifier: 00878953003931
• UDI-Public: 00878953003931
• 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: 2015
• 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): 07/15/2021

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: 02/20/2018
• Device Model Number: 72404291
• Device Catalogue Number: 72404291
• Device Lot Number: 816333001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 07/15/2021
• 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: PUMP,MODEL # 72404310,LOT # 908921003.; PUMP,MODEL # 72404310,LOT # 908921003.; PUMPMODEL # 72404310LOT # 908921003
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR