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

Model Number	72404173
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Perforation (2001)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: based on the information available, there was no device available for analysis and the most probable cause of the reported migration and malposition could not be determined.The reported patient symptom of perforation is a known risk associated with inflatable penile prosthesis (ipp) procedures and is noted as such in the ams 700 instructions for use.Device history record (dhr): the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: the ams 700 instructions for use (ifu) was reviewed.The patient symptom of perforation was found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient presented to their physician with a penile deformity related to this inflatable penile prosthesis (ipp).Upon examination, it was determined that the left cylinder had migrated and extruded through the cavernosum at the site of the corporotomy.It was noted that the cylinder still inflated as expected, but was sitting under the skin rather than within the cavernosum.The patient has been scheduled for a procedure on a future date to surgically address the issue.No additional patient complications were reported.
Additional Manufacturer Narrative
Investigation summary: based on the information available, there was no device available for analysis and the most probable cause of the reported migration and malposition could not be determined.The reported patient symptom of perforation is a known risk associated with inflatable penile prosthesis (ipp) procedures and is noted as such in the ams 700 instructions for use.Device history record (dhr): the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: the ams 700 instructions for use (ifu) was reviewed.The patient symptom of perforation was found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient presented to their physician with a penile deformity related to this inflatable penile prosthesis (ipp).Upon examination, it was determined that the left cylinder had migrated and extruded through the cavernosum at the site of the corporotomy.It was noted that the cylinder still inflated as expected, but was sitting under the skin rather than within the cavernosum.The patient underwent revision surgery and the left cylinder was repositioned back into place.The surgeon concluded that poor tissue quality after radiation treatment was the most likely cause of the device migrating.There were no further patient complications reported.

• 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: 14190602
• Report Number: 2124215-2022-12535
• Device Sequence Number: 11863723
• Product Code: FHW
• UDI-Device Identifier: 00878953003276
• UDI-Public: 00878953003276
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

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: 03/22/2021
• Device Model Number: 72404173
• Device Catalogue Number: 72404173
• Device Lot Number: 1000250385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2019
• 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: Required Intervention; Hospitalization; Other
• Patient Age: 76 YR
• Patient Sex: Male