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

Model Number	72404287
Medical Device Problem Codes	Collapse (1099); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event was not provided.
Event or Problem Description
It was reported that the patient is experiencing a flat inflatable penile prosthesis (ipp) pump.During activation, the pump stayed flat and did not refill.The physician tried to unlock the pump but was unsuccessful, and recommends a surgery to explant the device.No patient complications were reported.
Additional Manufacturer Narrative
The following fields have been updated: b2: outcomes attributed to adv event.B5: event description.B6: impact code.
Event or Problem Description
It was reported that the patient is experiencing a flat inflatable penile prosthesis (ipp) pump.During activation, the pump stayed flat and did not refill.The physician was unsuccessful in their attempt to lock the pump, and recommends a surgery to explant the device.At a later date, the patient had a surgical procedure to replace the reservoir.The new pre-connected ms pump locked after two weeks after working well; since the last revision the reservoir was not changed, the idea is to change the ipp device according to the test during the surgery.No patient complications were reported.
Additional Manufacturer Narrative
The following fields have been updated: b2 outcomes attributed to adv event.B5 event description.B6 impact code.
Event or Problem Description
It was reported that the patient is experiencing a flat inflatable penile prosthesis (ipp) pump.During activation, the pump stayed flat and did not refill.The physician was unsuccessful in their attempt to lock the pump, and recommends a surgery to explant the device.At a later date, the patient had a surgical procedure to replace the reservoir.The new pre-connected ms pump locked after two weeks after working well; since the last revision the reservoir was not changed, the ipp reservoir was replaced at a later date.No patient complications were reported.

• 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; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 13173287
• Report Number: 2124215-2021-39336
• Device Sequence Number: 14592994
• Product Code: FHW
• UDI-Device Identifier: 00878953003900
• UDI-Public: 00878953003900
• 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: 2021
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 09/28/2022

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: 10/21/2024
• Device Model Number: 72404287
• Device Catalogue Number: 72404287
• Device Lot Number: 1000346981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 05/10/2022; 09/16/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 06/06/2022; 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Male