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

Model Number	72401850
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that due to a malfunction from twisting of the connecting tube and connector tip crack the patient had his inflatable penile prosthesis (ipp) revised.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS ACCESSORY KIT
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 10417873
• Report Number: 2183959-2020-03543
• Device Sequence Number: 14173158
• Product Code: FHW
• UDI-Device Identifier: 00878953001135
• UDI-Public: 00878953001135
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2020

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: 01/15/2025
• Device Model Number: 72401850
• Device Catalogue Number: 72401850
• Device Lot Number: 1000382450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR