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

Model Number	72404310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994)
Date of Event	11/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had his spectra penile prosthesis (spp) removed due to pain in the glans or scrotum.The pain originated in the soft tissue because of the pump.The physician feels the pain was caused by the patient's infection.The patient status following this surgery was "not bad.".
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the returned device was visually and functionally tested.Visual inspection of the momentary squeeze (ms) pump found the kink resistant tubing (krt) was worn to the filament; however, no leaks were present.Functional testing noted the pump failed the activation test requiring more force than specification to activate.Product analysis was unable to confirm the reported events but did identify a pump malfunction.Visual inspection and functional testing of the cylinders found no evidence of leaks; the cylinders performed within specification.The spherical reservoir was visually inspected and functionally tested during which a leak was identified in the krt at the reservoir adapter strain relief junction as a result of fatigue; a hole was observed.The reservoir was noted to demonstrate wear at a fold in the reservoir shell but no leak was identified.Analysis identified a malfunction with the returned reservoir.Analysis could not confirm the reported events but did identify malfunctions in the ms pump and reservoir components.There is no objective evidence that the user did not properly handle or use the device according to the instructions for use (ifu).Additionally, the reported events do not contain an allegation against the labeling.Product record review confirmed the reported events do not represent an unanticipated event nor did the device fail to meet applicable product specifications prior to shipment from boston scientific.An investigation conclusion code of known inherent risk of device was chosen as a product malfunction related to the reported events was not identified and the adverse events of pain and infection are included in the product labeling and hazard analysis.
Event or Problem Description
It was reported that the patient had his inflatable penile prosthesis (ipp) removed due to pain in the glans and scrotum.The pain originated in the soft tissue because of the pump.Pus was also found in the scrotum.The physician feels the pain was caused by the patient's infection.The patient status following this surgery was "not bad." a spectra malleable penile prosthesis was implanted after treatment of inflammation.
Event or Problem Description
It was reported that the patient had his inflatable penile prosthesis (ipp) removed due to pain in the glans or scrotum.The pain originated in the soft tissue because of the pump.Pus was also found in the scrotum.The physician feels the pain was caused by the patients infection.The patient status following this surgery was "not bad." the device was re-implanted after treatment of inflammation.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the returned device was visually and functionally tested.Visual inspection of the momentary squeeze (ms) pump found the kink resistant tubing (krt) was worn to the filament; however, no leaks were present.Functional testing noted the pump failed the activation test requiring more force than specification to activate.Product analysis was unable to confirm the reported events but did identify a pump malfunction.Visual inspection and functional testing of the cylinders found no evidence of leaks; the cylinders performed within specification.The spherical reservoir was visually inspected and functionally tested during which a leak was identified in the krt at the reservoir adapter strain relief junction as a result of fatigue; a hole was observed.The reservoir was noted to demonstrate wear at a fold in the reservoir shell but no leak was identified.Analysis identified a malfunction with the returned reservoir.Analysis could not confirm the reported events but did identify malfunctions in the ms pump and reservoir components.There is no objective evidence that the user did not properly handle or use the device according to the instructions for use (ifu).Product record review confirmed the reported events do not represent an unanticipated event nor did the device fail to meet applicable product specifications prior to shipment from boston scientific.An investigation conclusion code of known inherent risk of device was chosen as a product malfunction related to the reported events was not identified and the adverse events of pain and infection are included in the product labeling and hazard analysis.Patient codes: inflammation added.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 10905592
• Report Number: 2183959-2020-05610
• Device Sequence Number: 16341755
• Product Code: FHW
• UDI-Device Identifier: 00878953005201
• UDI-Public: 00878953005201
• 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: 2018
• Device Explanted Year: 2020
• 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,Followup
• Report Date (Section B): 03/10/2021

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: Lay User/Patient
• Device Expiration Date: 07/21/2022
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 0181501006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 12/08/2020; 02/16/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/17/2020; 03/10/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 57 YR