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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404233
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Erosion (1750); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Fibrosis (3167)
Event Date 08/22/2021
Event Type  Injury  
Event Description
It was reported that the patient experienced urinary retention, penile pain and the inflatable penile prosthesis (ipp) on the right corpora had eroded into the urethra, completely obstructing it.An explant procedure was performed, in which the existing cylinders and pump were removed.During the procedure, heavy scar tissue and fibrosis was identified in the region of the ring; therefore, to avoid injury the reservoir was left in situ.A full cystourethroscopy was performed, there were no foreign bodies left in the urethra or bladder.After a foley catheter was placed, there was clear yellow urine draining appropriately.There were no further patient complications.
 
Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this ams 700 underwent a thorough analysis.The cylinders were visually and microscopically examined.The first cylinder outer fabric thread tubing was detached from the medial of the cylinder body.The inner tubing was not damaged, and no anomalies were seen upon leak testing.The second cylinder had wear at a fold on the medial, close to the distal end of the cylinder body.The component outer tubing was detached; however, it likely occurred during explant.The second cylinder did not present leaks within the inner tubing and performed within specification.Under the microscope, the proximal outer tubing had wear against the kink resistant tubing (krt) and was worn down to filament.Scaling was also identified by the outer tubing war and within the corner of the folds.Additionally, the fabric threads were found to be worn down.The pump was visually and microscopically examined.Although the pump krt was worn down to the filament, no leaks were identified.Upon functional testing, the pump did not pass the activations test.The reported patient symptoms are known risks associated with ams 700 procedures and are noted as such in the device instructions for use.Based on the information available and analysis results, although the reported allegations could not be confirmed, the identified device anomalies could affect the ams 700 functionality.
 
Event Description
It was reported that the patient experienced urinary retention, penile pain and the inflatable penile prosthesis (ipp) on the right corpora had eroded into the urethra, completely obstructing it.An explant procedure was performed, in which the existing cylinders and pump were removed.During the procedure, heavy scar tissue and fibrosis was identified in the region of the ring; therefore, to avoid injury the reservoir was left in situ.A full cystourethroscopy was performed, there were no foreign bodies left in the urethra or bladder.After a foley catheter was placed, there was clear yellow urine draining appropriately.There were no further patient complications.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Type of Device
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
MDR Report Key15670846
MDR Text Key302396945
Report Number2124215-2022-43315
Device Sequence Number1
Product Code FHW
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/25/2012
Device Model Number72404233
Device Catalogue Number72404233
Device Lot Number661840001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
RESERVOIR: 72404155/695742003; RESERVOIR: 72404155/695742003
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age86 YR
Patient SexMale
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