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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number UNK-P-IPP
Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)
Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Event Date 08/01/2020
Event Type  Injury  
Event Description
It was reported that the patient visited his physician and the physician stated that he can hear air in the patient's current device.Due to this, the patient will have his ambicor penile prosthesis (app) revised on a future date.If possible explanted components will be returned for testing.
 
Manufacturer Narrative
Correction: fluid loss coding added to this report.
 
Event Description
It was reported that the patient visited his physician and the physician stated that he can hear air in the patient's current device.Due to this, the patient will have his ambicor penile prosthesis (app) revised on a future date.If possible explanted components will be returned for testing.
 
Manufacturer Narrative
Product investigation: the ams 700 ipp device has been returned and is currently undergoing product analysis.
 
Event Description
It was reported that this patient underwent a surgical procedure to replace his inflatable penile prothesis (ipp) due to a leak found from a crease in the reservoir.Previous to this surgery, the physician could hear air in the patients device.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
 
Event Description
It was reported, that this patient underwent a surgical procedure.To replace his inflatable penile prothesis (ipp), due to a leak found from a crease in the reservoir.Previous to this surgery, the physician could hear air in the patients device.Boston scientific has been unable to obtain additional information, regarding the patient outcome to date, despite good faith efforts.
 
Manufacturer Narrative
Investigation summary: the device was returned for analysis.Product analysis was able to confirm, the reported event.Device history record (dhr): a dhr and ship history review cannot be performed, as the lot number was not available.Device technical analysis: the ams 700 spherical reservoir was visually inspected, and leak tested.A fluid leak was identified, in the reservoir shell attributed to wear and fatigue at the corner of a fold.The (b)(6) cylinders were visually inspected and leak tested.Both cylinders had a leak near the proximal end of the cylinder body attributed to sharp instrument damage consistent with explant.Due to this damage being consistent with explant, it will be considered a secondary failure.The ms pump was visually inspected, and leak tested.The kink resistant tubing (krt) was worn to the filament.However, no leaks were present.Microscopic inspection identified, contamination resulting in an inability to functionally test the pump.Labeling review: there is no objective evidence, that the user did not properly handle or use the device according to the ifu, ams700 ms pump.The reported events, also do not contain an allegation against the labeling.Investigation conclusion: based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key10474786
MDR Text Key205086953
Report Number2183959-2020-03874
Device Sequence Number1
Product Code FHW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup,Followup,Followup
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberUNK-P-IPP
Device Catalogue NumberUNK-P-IPP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2021
Date Manufacturer Received03/18/2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age65 YR
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