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

Model Number	72404300
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
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 had the inflatable penile prosthesis cylinders and pump removed due to a cylinder micro puncture and pump malfunction.New inflatable penile prosthesis cylinders and pump were implanted.Following the surgery the event resolved.
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis cylinders and pump removed due to a cylinder micro puncture and pump malfunction.New inflatable penile prosthesis cylinders and pump were implanted.Following the 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 hole resulting in fluid leak and pump mechanical issue was not confirmed.Device history record review (dhr): the device history record review (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The ams700 ipp cylinder was visually inspected, leak tested and examined using a microscope.The cylinder had wear at a fold in the proximal cylinder body.There was a leak in the distal cylinder body from a hole through the front tip.This hole was the result of a sharp instrument damage which probably occurred during the explant surgery.The cylinder was not pressure test due to leak that was identified.The ams700 momentary squeeze (ms) pump was leak tested, visually inspected, examined using a microscope, and functionally tested.The pump was functionally tested and performed within specification.Product analysis was unable to confirm the reported events.Labeling review: a labeling review found no evidence of device off-label use or failure to follow instructions for the device.Investigation conclusion: based on this investigation a clear probable cause for the event was established; therefore, the investigation conclusion code of cause not established was chosen because cylinder was identified to be damaged as sharp instrument damage was identified and it will be considered a secondary failure.Therefore, the most probable cause could not be confirmed.

• 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; malborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 12647467
• Report Number: 2124215-2021-31218
• Device Sequence Number: 1375889
• Product Code: FHW
• UDI-Device Identifier: 00878953005713
• UDI-Public: 00878953005713
• 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: 2020
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 12/06/2021

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: 01/07/2025
• Device Model Number: 72404300
• Device Catalogue Number: 72404300
• Device Lot Number: 1000376573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2020
• 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: RESERVOIRMODEL #72404161LOT # 1000352217; RESERVOIRMODEL #72404161LOT # 1000352217; RESERVOIRMODEL #72404161LOT # 1000352217
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male