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

Model Number	72404266
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis removed due to cylinder aneurysm.A new inflatable penile prosthesis was implanted.No further complications were reported in relation to this event.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concluded based on the product analysis results, the cylinder bulge affected the functionality of the device.Product analysis confirmed the cylinder bulge.Device history record review (dhr): the device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.A risk review confirmed that the event is accounted for in the risk documentation, and a labeling review found no evidence of device off-label use or failure to follow instructions.Device technical analysis: visual inspection of the ams700 indicated that the ams 700 momentary squeeze (ms) pump was leak tested.The kink resistant tubing (krt) was worn to the filament; however, no leaks were present.The pump was functionally tested and failed the 8lb.Activation test (2).The pump therefore required more than 8lbs.Of force to activate.The ams700 ipp cylinders were leak tested.Cylinder 1 has broken fabric treads in proximal cylinder body and exhibited bulging when inflated; no leak was found.Cylinder 1 was not pressure tested due to bulge was identified.Cylinder 2 was pressure tested and performed within specification; no leak was found.Both cylinders had wear at fold in cylinder body.The krt of both cylinders were worn to filament; no leak was found in the krt.Product analysis confirmed the reported event.Labeling review: there is no objective evidence that the user did not properly handle or use the device according to the ifu, ams700 ms pump.Additionally, the reported events do not contain an allegation against the labeling.Investigation conclusion: the investigation conclusion code of cause traced to component failure was chosen because the reported events could be traced to a component failure.
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis removed due to cylinder aneurysm.A new inflatable penile prosthesis was implanted.No further complications were reported in relation to this event.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11464140
• Report Number: 2183959-2021-00908
• Device Sequence Number: 3360004
• Product Code: FHW
• UDI-Device Identifier: 00878953003740
• UDI-Public: 00878953003740
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 10/03/2018
• Device Model Number: 72404266
• Device Catalogue Number: 72404266
• Device Lot Number: 0151177001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR