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

Model Number	72404250
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	02/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) surgery due to the device not working.It was said that the right cylinder was disrupted.Both cylinders outer layer dislodged from inner fabric layer and the dacron layer was torn.The device was removed and there were no patient complications.
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) surgery due to the device not working.It was said that the right cylinder was disrupted.Both cylinders outer layer dislodged from inner fabric layer and the dacron layer was torn.The device was removed and there were no patient complications.
Additional Manufacturer Narrative
Investigation summary: laboratory analysis confirmed the reported clinical observation of pump non conformance but it did not confirm the reported clinical observation of hole/perforated.Product analysis concluded that the activation anomalies could affect the functionality of the device as the reported mechanical non conformance.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 inflatable penile prosthesis (ipp) was thoroughly analyzed.The cylinders were visually and microscopically inspected, and functionally tested.The pump was functionally tested.The cylinders were not leak and pressure tested due to leaks that were caused by damages that occurred during explant.The pump did not passed the functional test since it did not pass the activation and valve deactivate test.Product analysis concluded these activation issues could affect the functionality of the device as the reported mechanical issue.Product analysis confirmed a pump non-conformance but was unable to confirm the reported allegation related to device has a hole/perforated.Labeling review: there is no objective evidence that the user did not properly handle or use the device according to the ipp instructions for use (ifu).Investigation conclusion: an overall evaluation conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) surgery due to the device not working.It was said that the right cylinder was disrupted.Both cylinders outer layer dislodged from inner fabric layer and the dacron layer was torn.The device was removed and there were no patient complications.

• 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
• 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 ; 4089353452
• MDR Report Key: 13573760
• Report Number: 2124215-2022-05259
• Device Sequence Number: 4674036
• Product Code: FHW
• UDI-Device Identifier: 00878953003580
• UDI-Public: 00878953003580
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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: 12/07/2018
• Device Model Number: 72404250
• Device Catalogue Number: 72404250
• Device Lot Number: 0157626004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2016
• 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: RESERVOIR:UPN: 720185-01LOT: 1000023409; RESERVOIR:UPN: 720185-01LOT: 1000023409
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male