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

Model Number	72404283
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event entered is an estimated date as the exact date of event was not provided.
Event or Problem Description
It was reported the patient will have his inflatable penile prosthesis revised on a future date due to fluid loss and an inability to inflate the device.No patient complications were reported in relation to this event.Additional information received states the inflatable penile prosthesis (ipp) device was explanted.A new 21cm x 12mm ipp device with 100ml reservoir was implanted.Further information was requested and not yet received.Product was explanted but not expected to be returned.Should additional information be received or product be returned, a supplemental report will be filed upon completion of product analysis.This report was originally submitted via asr.Report id number for the event: (b)(4).Quarter/year of initial asr report submitted to fda: q1/2017.Asr exemption number: e1197037.
Additional Manufacturer Narrative
Device evaluation provided in: d10, h3 and h6.Device evaluation: the ams700 ipp cylinders were visually inspected and functionally tested; no leaks were found.The cylinders performed within specification.The ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.The pump was functionally tested and failed the activation test.Device analysis was unable to confirm the allegation related to a fluid leak; however, the identification of the pump functional test failure would confirm an inflation issue.The ams 700 spherical reservoir was visually inspected and functionally tested; a leak was present in the reservoir shell that was the result of wear at the corner of a fold.This leak would therefore confirm the fluid leak allegations.It would also affect the functionality of the device and therefore confirm an inflation issue.Additional manufacturer narrative: b3 - date of event entered is an estimated date as the exact date of event was not provided.
Event or Problem Description
It was reported the patient will have his inflatable penile prosthesis revised on a future date due to fluid loss and an inability to inflate the device.No patient complications were reported in relation to this event.Additional information received states the inflatable penile prosthesis (ipp) device was explanted.A new 21cm x 12mm ipp device with 100ml reservoir was implanted.Further information was requested and not yet received.Product was explanted but not expected to be returned.Should additional information be received or product be returned, a supplemental report will be filed upon completion of product analysis.This report was originally submitted via asr.Report id number for the event: (b)(4).Quarter/year of initial asr report submitted to fda: q1/2017.Asr exemption number: e1197037.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9193712
• Report Number: 2183959-2019-66850
• Device Sequence Number: 3730965
• Product Code: FHW
• UDI-Device Identifier: 00878953003863
• UDI-Public: 00878953003863
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

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: 04/03/2018
• Device Model Number: 72404283
• Device Catalogue Number: 72404283
• Device Lot Number: 823666004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 02/08/2020
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 02/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR