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

Model Number	72404302
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) had a posterior extension body installed on the left side and no posterior extension body installed on the right side.The patient experienced pain during the procedure, and an infection was found a few days later.There was no improvement after detoxification and drainage treatment.The ipp was explanted and will be re-implanted six months later.There were no additional patient complications reported.
Additional Manufacturer Narrative
Correction to b5 with additional details.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) had a posterior extension body installed on the left side and no posterior extension body installed on the right side.The patient experienced pain during the procedure, and an infection was found a few days later in the scrotum extending to the corpus cavernosum.The physician suspected that the patient blood sugar was not controlled very well.There was no improvement after detoxification and drainage treatment.The ipp was explanted and will be re-implanted six months later.There were no additional patient complications reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) had a posterior extension body installed on the left side and no posterior extension body installed on the right side.The patient experienced pain during the procedure, and an infection was found a few days later in the scrotum extending to the corpus cavernosum.The physician suspected that the patient blood sugar was not controlled very well.There was no improvement after detoxification and drainage treatment.The ipp was explanted and will be re-implanted six months later.There were no additional patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The first cylinder was microscopically inspected and had wear at fold in the proximal end of the cylinder.The first cylinder had a hole with a leak in the proximal end of the cylinder from sharp instrument.The first cylinder had tool marks along the cylinder body.The second cylinder was microscopically inspected and had wear at fold in the middle of the cylinder.The second cylinder had two holes with a leak in the proximal end of the cylinder from sharp instrument.The momentary squeezed (ms) pump kink resistant tubing (krt) was microscopically inspected and had a small hole/leak from sharp instrument damage.The ms pump krt were cut shorter for functional testing.The pump had a small leak in the reservoir krt from sharp instrument damage.The ms pump did not pass activation testing.The flat reservoir passed visual inspection and leakage test.This investigation was assigned to the conclusion code of known inherent risk of device.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20029794
• Report Number: 2124215-2024-51162
• Device Sequence Number: 8601216
• Product Code: FHW
• UDI-Device Identifier: 00878953005737
• UDI-Public: 00878953005737
• 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 Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2024

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: Lay User/Patient
• Device Model Number: 72404302
• Device Catalogue Number: 72404302
• Device Lot Number: 1100439791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 08/29/2024; 10/10/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/19/2024; 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR UPN 720182-01 / LOT 1100478364; RESERVOIR UPN 720182-01 / LOT 1100478364; RESERVOIR UPN 720182-01 / LOT 1100478364; RTE: UPN 72404321/ LOT 1100429966; RTE: UPN 72404321/ LOT 1100429966; RTE: UPN 72404321/ LOT 1100429966
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Male