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

Model Number	72401850
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) cylinders flushed out of the urinary tract; therefore, the patient underwent a reconstructive penoplasty to repair the damaged urethra; also, the cylinders were removed and replaced with new ones.There were no additional patient complications reported.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed or the cause that contributed to the event be established.The reported clinical observations of perforation and device migration are known risks associated with the procedure and indicated in the labeling.
Event or Problem Description
It was reported that the cylinders of this inflatable penile prosthesis (ipp) flushed out of the urinary tract; therefore, the patient underwent penoplasty to repair the damaged urethra; also, the cylinders were removed and replaced with new ones.There were no additional patient complications reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS ACCESSORY KIT
• 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
• MDR Report Key: 14917989
• Report Number: 2124215-2022-24068
• Device Sequence Number: 2033218
• Product Code: FHW
• UDI-Device Identifier: 00878953001135
• UDI-Public: 00878953001135
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

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: 07/22/2026
• Device Model Number: 72401850
• Device Catalogue Number: 72401850
• Device Lot Number: 1000592142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 80 KG