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

Model Number	72404261
Medical Device Problem Codes	Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was not provided so an approximate date was provided.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Neither the reported patient symptoms or device performance allegation can be confirmed.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 is requesting a revision of an inflatable penile prosthesis (ipp) due to inflation issues.The patient is unable to completely inflate the ipp.A revision surgery has not yet occurred.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
Investigation summary: based on the information available boston scientific concludes, based on product analysis, that the pump activation issue likely caused or contributed to the clinical observation of inflation difficulty.Device history record (dhr) review: device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Device technical analysis: upon receipt at our quality assurance laboratory, this device underwent a thorough analysis.The ms (momentary squeeze) pump was leak tested, visually inspected, examined using a microscope, and functionally tested.The pump kink resistant tubing (krt) was worn down to the filament; this did not likely affect device function.The pump did not pass valve deactivation functional testing.The ams700 ipp cylinders were visually inspected, leak tested, and examined using a microscope.Both cylinders had folds that indicate possible buckling of the cylinders in the proximal cylinder body.A leak was present that was consistent with explant damage.The rear tip of one cylinder was found to have been trimmed and shaved down.Both cylinders were not pressure tested due to the identified leak.Product analysis confirmed the reported event.Labeling review: a labeling review was performed and according to the ifu (instruction for use), there is no evidence that the device was used or handled improperly.Investigation conclusion: based on the information available, a conclusion code of caused traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) requested a revision due to inability to completely inflate the ipp.The device was explanted and returned for analysis; no information was provided regarding device replacement.No patient complications were reported.

• 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: 12642946
• Report Number: 2124215-2021-31133
• Device Sequence Number: 19745565
• Product Code: FHW
• UDI-Device Identifier: 00878953003696
• UDI-Public: 00878953003696
• Combination Product (Y/N): Y
• Initial Reporter Country: TU
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/26/2015
• Device Model Number: 72404261
• Device Catalogue Number: 72404261
• Device Lot Number: 821452003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2013
• 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
• Patient Sex: Male