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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 72404310
Device Problem Collapse (1099)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2020
Event Type  Injury  
Event Description
It was reported that due to pump bulb staying flat when pressing the patient had his inflatable penile prosthesis (ipp) pump removed and replaced.The patient visited the hospital for this issue two weeks before this surgery.The patient is stable following this surgery.
 
Manufacturer Narrative
Product analysis was unable to confirm to reported events related to pump collapse, 'pump bulb staying flat' issue.The ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.Contamination was found inside pump.The pump was not functionally tested due to contamination.Product analysis was unable to confirm the reported event.The product record review indicated reported events do not represent an unanticipated event.Review of the manufacturing documentation confirmed all required in-process and final inspections and testing were completed.Based on this investigation, the investigation conclusion code of 'cause not established' was chosen because the reported events could not be confirmed or substantiated through investigation.Based on the results of this investigation, no escalation is required.This conclusion is supported by the following objective evidence: product analysis summary product analysis was unable to confirm to reported events related to pump collapse, 'pump bulb staying flat' issue.The ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.Contamination was found inside pump.The pump was not functionally tested due to contamination.Product analysis was unable to confirm the reported event.Dhr review / similar complaint review 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 batch 1000193379 and it respective container 22945010, found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.Additionally, potential emerging trends are captured as part of the post market signal evaluation and escalation process.Risk review the ams 700 hazard analysis indicates that the as reported events of this complaint do not represent a new hazardous situation.Additionally, boston scientific does not have responsibility to provide training to medical professional as documented in the dfu/ifu, and the ams 700 is not a new product because it is not within the first six months of its release in any geography, and it is not a new design platform.No further review is required.
 
Event Description
It was reported that due to pump bulb staying flat when pressing the patient had his inflatable penile prosthesis (ipp) pump removed and replaced.The patient visited the hospital for this issue two weeks before this surgery.The patient is stable following this surgery.The ams 700 momentary squeeze (ms) pump was returned for analysis.The pump was visually inspected; no leaks were found.Contamination was found inside pump.The pump was not functionally tested due to contamination.Product analysis was unable to confirm the reported event.
 
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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 Key10242241
MDR Text Key197853104
Report Number2183959-2020-02815
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003986
UDI-Public00878953003986
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 08/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/15/2023
Device Model Number72404310
Device Catalogue Number72404310
Device Lot Number1000193379
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2020
Date Manufacturer Received07/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age70 YR
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