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

Model Number	72404267
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 720185-01, batch/lot number: 704281020, model/catalog description: reservoir flat iz 100 ml.
Event or Problem Description
It was reported that the patient experienced spontaneous inflation with an inflatable penile prosthesis (ipp).A replacement surgery was performed.The patient was concerned about a possible infection, but it was confirmed that the patient did not present signs of infection.The patient was reported to be fine after the procedure.No more information available at the moment.Should additional information become available, it will be provided.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01, serial number: null, batch/lot number: 704281020.Model/catalog description: reservoir flat iz 100 ml.Product investigation summary: it was reported that the patient experienced spontaneous inflation with an inflatable penile prosthesis (ipp).A replacement surgery was performed.The patient was concerned about a possible infection, but it was confirmed that the patient did not present signs of infection.The patient was reported to be fine after the procedure.No more information available at the moment.Should additional information become available, it will be provided.Analysis of the cxr preconnect ms 14cm ip iz confirmed there were no leaks in cylinder 1.Cylinder 2 had a leak at the cylinder body due to a hole in the outer tube and wear at the fold.The pump had no significant damage.Review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records for tcf 700624 found no evidence that the device failed to meet applicable product specifications prior to shipment from bsc.Ship history, labeling review and risk review not required per 92186855 wi cis product investigation.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered cause traced to component failure.This complaint investigation conclusion code is utilized for an expected or random component failure without any design or manufacturing issue.Based on the results of this investigation, no escalation is necessary.
Event or Problem Description
It was reported that the patient experienced spontaneous inflation with an inflatable penile prosthesis (ipp).A replacement surgery was performed.The patient was concerned about a possible infection, but it was confirmed that the patient did not present signs of infection.The patient was reported to be fine after the procedure.No more information available at the moment.Should additional information become available, it will be provided.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8625595
• Report Number: 2183959-2019-63271
• Device Sequence Number: 11285537
• Product Code: FHW
• UDI-Device Identifier: 00878953003757
• UDI-Public: 00878953003757
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

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: 03/02/2013
• Device Model Number: 72404267
• Device Catalogue Number: 72404267
• Device Lot Number: 700624003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 06/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR