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

Model Number	72404162
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient had a surgical procedure to replace an inflatable penile prosthesis (ipp) due to a puncture in the reservoir.No patient complications were reported.
Event or Problem Description
It was reported that the patient had a surgical procedure to replace an inflatable penile prosthesis (ipp) due to a puncture in the reservoir.No patient complications were reported.
Additional Manufacturer Narrative
Investigation summary: based on the information available, product analysis was able to confirm the reported event.Device history record (dhr): the device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the ams700 ipp spherical reservoir was visually inspected, leak tested and examined using a microscope.The reservoir has holes which led to leaks in the reservoir shell that was the result of a sharp instrument damage which probably occurred during the implant surgery.Labeling review: the device instructions for use (ifu) was performed based on the conclusion that it is possible sharp instrument damage occurred during the implant procedure.The following statements were identified, do not use product that has damaged or open packaging, as sterility may be compromised;unsuccessful outcomes have been reported due to improper surgical technique, anatomical misplacement of components, improper sizing and filling of components, or tubing kinks.It can therefore be concluded that the proper warnings are identified in the ifu.Additionally, the reported events do not contain an allegation against the labeling.Investigation conclusion: based on the information available, a conclusion code of unintended use error caused or contributed to this event was assigned to this investigation.

• 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: 12518154
• Report Number: 2124215-2021-28522
• Device Sequence Number: 11785873
• Product Code: FHW
• UDI-Device Identifier: 00878953003245
• UDI-Public: 00878953003245
• 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: 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): 10/20/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2024
• Device Model Number: 72404162
• Device Catalogue Number: 72404162
• Device Lot Number: 1000341273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PUMPMODEL 7204302LOT 1000542124; PUMPMODEL 7204302LOT 1000542124; PUMPMODEL 7204302LOT 1000542124
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR