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

Model Number	72404303
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	06/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the inflatable penile prosthesis (ipp) cylinders and pump were explanted due to erosion.It was further reported that three weeks prior to surgery the device would not inflate.During the surgery it was identified that the cylinders had eroded at the cavernous body.
Event or Problem Description
It was reported that the inflatable penile prosthesis (ipp) cylinders and pump were explanted due to erosion.It was further reported that three weeks prior to surgery the device would not inflate.During the surgery it was identified that the cylinders had eroded at the cavernous body.
Additional Manufacturer Narrative
Device analysis: a device inflation issue was reported.The ams700 device was visually inspected.There was a leak in one-cylinder input tube that was the result of a sharp instrument damage consistent with explant damage.Based on the determination that the leak in the cylinder input tube was the result of explant damage it is considered a secondary failure and will not be considered a probable cause for the reported events.The other cylinder performed within specifications.The pump was not functionally tested due to a leak in one-cylinder tube near the pump block due to wear and fatigue.The leak in the pump cylinder tube would result in the loss of fluid and an eventual inability to inflate the cylinders; therefore, the reported allegation of a device inflation issue is confirmed.The investigation conclusion code of cause traced to component failure was chosen based on the facts that the reported allegations can be traced to a component failure identified during product analysis.Based on the results of this investigation, no escalation is required.If further information is received at a later date, the product investigation will be reopened to address the additional information.

• 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: 8804145
• Report Number: 2183959-2019-65135
• Device Sequence Number: 18912130
• Product Code: FHW
• UDI-Device Identifier: 00878953005744
• UDI-Public: 00878953005744
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: GR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

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: 09/25/2022
• Device Model Number: 72404303
• Device Catalogue Number: 72404303
• Device Lot Number: 0188987007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 10/04/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention