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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 72404013
Device Problems Failure to Cycle (1142); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2019
Event Type  Injury  
Manufacturer Narrative
Additional product component: model number/catalog number 72404310, serial number: null and null, batch/lot number 131026001, model/catalog description pump ms.
 
Event Description
It was reported that the patient underwent a revision procedure due to a cylinder connector disorder with an inflatable penile prosthesis (ipp).The ipp right cylinder and pump was explanted and a new ipp right cylinder and pump was implanted.Additional information was reported that the connector did not stay straight, with continuous chafed by the skin wearing down the connector and the patient had difficulties inflating/deflating the cylinder.The patient presented to the physician two weeks prior to the revision surgery.
 
Manufacturer Narrative
Cylinder analysis: product analysis identified a leak in the input tube krt due to fatigue.The reported events indicate an allegation of connector disorder, however, based on the proximity of the leak to the connector, the identified tubing leak is the most probable cause for the reported events.The investigation conclusion code of cause traced to component failure was chosen because a device malfunction was identified during product analysis that could be traced to a component failure.Based on the results of this investigation no escalation is required.Pump analysis: product analysis was unable to confirm a device malfunction with the pump.Refer to tw#11741541 for analysis of the cylinder in which a device malfunction was confirmed.Based on this investigation, the investigation conclusion code of no problem detected was chosen because the reported events could not be confirmed or substantiated through investigation of the pump component.Based on the results of this investigation, no escalation is required.Additional product component: model number/catalog number 72404310.Serial number: null and null.Batch/lot number 131026001.Model/catalog description pump ms.
 
Event Description
It was reported that the patient underwent a revision procedure due to a cylinder connector disorder with an inflatable penile prosthesis (ipp).The ipp right cylinder and pump was explanted and a new ipp right cylinder and pump was implanted.Additional information was reported that the connector did not stay straight, with continuous chafed by the skin wearing down the connector and the patient had difficulties inflating/deflating the cylinder.The patient presented to the physician two weeks prior to the revision surgery.
 
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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 Key9405775
MDR Text Key169001035
Report Number2183959-2019-67856
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953002705
UDI-Public00878953002705
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 01/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/11/2020
Device Model Number72404013
Device Catalogue Number72404013
Device Lot Number926948004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2019
Date Manufacturer Received12/17/2019
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age56 YR
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