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

Model Number	72404162
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an inflatable penile prosthesis (ipp) reservoir placement in the pre-vesical space, the heart rate of the patient became unstable.The procedure was stopped and the reservoir removed.The patient was stabilized but the surgical team did not want to continue with the intervention until the patient gets a cardio assessment.The patient was stable and well following the procedure.It was unknown if the patient would proceed with a revision at a later date.
Additional Manufacturer Narrative
Investigation summary: the device was returned and thoroughly analyzed.The reservoir performed within specification and no leaks were found.Product analysis was unable to confirm the reported event.Based upon the information available, an unstable heart rate is not specifically related to the device and is a general surgical risk potentially related to anesthesia or irritation of the peritoneum during dissection.Dhr review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Technical analysis: the device was returned and thoroughly analyzed.Visual inspection of the reservoir did not identify any leaks in the component.Upon functional testing, it was discovered that the component performed within specification.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion: based on the information available, a conclusion code of adverse event related to patient condition was assigned to this investigation.
Event or Problem Description
It was reported that during an inflatable penile prosthesis (ipp) reservoir placement in the pre-vesical space, the heart rate of the patient became unstable.The procedure was stopped and the reservoir removed.The patient was stabilized but the surgical team did not want to continue with the intervention until the patient gets a cardio assessment.The patient was stable and well following the procedure.It was unknown if the patient would proceed with a revision at a later date.

• 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
• MDR Report Key: 11588243
• Report Number: 2183959-2021-01165
• Device Sequence Number: 4781495
• Product Code: FHW
• UDI-Device Identifier: 00878953003245
• UDI-Public: 00878953003245
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2024
• Device Model Number: 72404162
• Device Catalogue Number: 72404162
• Device Lot Number: 1000325182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR