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

Model Number	72404043
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It as reported that during an inflatable penile prosthesis implant, the physician felt that the device was not applicable, then replaced with a small one.There were no patient complications reported.The event resolved.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Device evaluation: the complaint components were returned and analyzed.The reported allegation of improper size was not confirmed via product analysis.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.
Event or Problem Description
It is reported that during an inflatable penile prosthesis implant, the physician felt that the device was not applicable, then replaced with a small one.There were no patient complications reported.The event resolved.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.Additional information received confirmed this was an original implant surgery.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS KIT
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8686415
• Report Number: 2183959-2019-63910
• Device Sequence Number: 2359387
• Product Code: FHW
• UDI-Device Identifier: 00878953002774
• UDI-Public: 00878953002774
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 07/29/2019

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: Health Professional
• Device Expiration Date: 01/18/2023
• Device Model Number: 72404043
• Device Catalogue Number: 72404043
• Device Lot Number: 1000040552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR