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

Model Number	72404268
Medical Device Problem Codes	Collapse (1099); Mechanical Problem (1384); Difficult or Delayed Activation (2577); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) exhibited activation issues which were noted approximately two months after implant at a follow-up appointment.Our records indicate that no revision surgery or surgical evaluation has been performed to date.No patient complications were reported.
Additional Manufacturer Narrative
Event date: exact event date unknown, activation issues were present during the first follow-up visit, two months after implantation.Investigation summary: based on the information available, the cause that contributed to the reported device issues cannot be established as the product is not available for analysis.Device history record (dhr): a dhr and ship history review cannot be performed as the lot number was not available.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Labeling review: a review of the ipp instructions for use 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 cause not established was assigned to this investigation.
Additional Manufacturer Narrative
Event date: exact event date unknown, activation issues were present during the first follow-up visit, two months after implantation.Investigation summary: based on the information available, the cause that contributed to the reported device issues cannot be established as the product is not available for analysis.Device history record (dhr): a dhr and ship history review cannot be performed as the lot number was not available.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Labeling review: a review of the ipp instructions for use 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 cause not established was assigned to this investigation.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) exhibited activation issues which were noted approximately two months after implant at a follow-up appointment.Our records indicate that no revision surgery or surgical evaluation has been performed to date.No patient complications were reported.
Additional Manufacturer Narrative
B3 event date: exact event date unknown, activation issues were present during the first follow-up visit, two months after implantation.Investigation summary: based on the information available, the cause that contributed to the reported device issues cannot be established as the product is not available for analysis.Device history record (dhr): a dhr and ship history review cannot be performed as the lot number was not available.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Labeling review: a review of the ipp instructions for use 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 cause not established was assigned to this investigation.
Event or Problem Description
It was reported that a patient implanted with this inflatable penile prosthesis (ipp) has experienced device performance issues, related to activation, since the first follow-up appointment.The patient subsequently underwent a replacement procedure during which it was noted that the pump bulb remained flat when pushed.Therefore, the entire ipp was removed and replaced.There were no patient complications reported.
Event or Problem Description
It was reported that a patient implanted with this inflatable penile prosthesis (ipp) has experienced device performance since the first follow-up appointment, related to activation issues.The patient subsequently underwent a replacement procedure, during which, it was noted that the pump bulb remained flat when pushed.Therefore, the entire ipp was removed and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
B3 event date: exact event date unknown, activation issues were present during the first follow-up visit, two months after implantation.Investigation summary: laboratory analysis confirmed the reported clinical observation of pump issues.The observed pump activation anomaly was determined to be the most probable cause of the reported events.Device history record (dhr) review: the dhr confirmed that the device met all material, assembly, and performance specifications.Technical analysis: upon receipt at our post market quality assurance laboratory, this ipp was thoroughly analyzed.The cylinders were visually inspected, microscopically examined, leak and pressure tested; all tests were passed.The pump was visually inspected, microscopically examined, leak and functionally tested.The pump did not pass the activation testing and its tubing was noted to be worn, which did not likely impact component performance.Product analysis confirmed the reported allegations, as the observed pump anomaly is likely to have affected the functionality of the device.Labeling review: there is no objective evidence that the user did not properly handle or use the device according to the ipp instructions for use.Investigation conclusion: an overall evaluation conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• 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 ; 4089353452
• MDR Report Key: 13503028
• Report Number: 2124215-2022-04165
• Device Sequence Number: 3992170
• Product Code: FHW
• UDI-Device Identifier: 00878953003764
• UDI-Public: 00878953003764
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2022

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: 10/18/2020
• Device Model Number: 72404268
• Device Catalogue Number: 72404268
• Device Lot Number: 1000179878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 02/22/2022; 03/30/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/10/2022; 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2018
• 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: 72404156/1000186745; RESERVOIR: 72404156/1000186745
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 66 YR
• Patient Sex: Male