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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINNETONKA AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC

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BOSTON SCIENTIFIC - MINNETONKA AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC Back to Search Results
Catalog Number SEE H10
Device Problems Tube (525); Fluid Leak (1250); Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Date 09/04/2018
Event Type  Injury  
Manufacturer Narrative

Model number: 72404173, expiration date: 07/11/2016, serial number: (b)(4), catalogue description: cx 18cm, snap fit rt iz, manufacture date: 07/28/2014. Model number: 72404155, expiration date: 04/23/2016, serial number: (b)(4), catalogue description: reservoir, 65ml, pc/iz, manufacture date: 05/22/2014. Device investigation: the ams700 device was visually inspected and functionally tested. There was a leak in the kink resistant tubing (krt) for the reservoir tube at the adapter - tubing junction that was the result of fatigue. Both cylinders have holes in the outer tube that were the result of a sharp instrument consistent with explant damage. Both cylinders are functional. The reservoir had a leak at the adapter - tubing junction that was the result of fatigue. The pump was not functionally tested due to the tubing leak.

 
Event Description

It was reported that the inflatable penile prosthesis (ipp) was explanted due to fluid loss from the tubing to the reservoir. The tubing was fractured. A new 18cm x 12mm ipp device was implanted. This complaint was initially submitted to fda via asr report 2018 and additional information was received by boston scientific. Due to the removal of exemption e1997037, this information is provided via supplemental report.

 
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Brand NameAMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Type of DeviceDEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC - MINNETONKA
10700 bren road w
minnetonka MN 55343
Manufacturer (Section G)
BOSTON SCIENTIFIC - MINNETONKA
10700 bren road w
minnetonka MN 55343
Manufacturer Contact
sharon zurn
10700 bren road w
minnetonka, MN 55343
9529306000
MDR Report Key8026927
MDR Text Key125743236
Report Number2183959-2018-00119
Device Sequence Number1
Product Code FHW
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberN970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 06/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/31/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue NumberSEE H10
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/03/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/31/2018 Patient Sequence Number: 1
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