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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 72404011
Device Problems Collapse (1099); Mechanical Problem (1384)
Patient Problem Erosion (1750)
Event Date 10/23/2019
Event Type  Injury  
Manufacturer Narrative
Pump: model- 72404310, lot sn- (b)(4), mfg date- 09/02/2015, exp date- 08/18/2020, gtin- (b)(4).Device not returned for evaluation.
 
Event Description
It was reported that due to the cylinder and pump breaking through the glans penis of cylinder and dimpled pump the patient had his inflatable penile prosthesis (ipp) cylinders and pump removed.The reservoir was plugged and remains implanted.It was further reported that the "cylinder's side at the glans penis damaged the tissue, so the cylinder extruded." the cylinder extruded out of the weak area.The extrusion occurred and the device stopped working 3 weeks ahead of surgery.The patient got well following this surgery.
 
Manufacturer Narrative
Pump model: 72404310.Lot sn: (b)(4).Mfg date: 09/02/2015.Exp date: 08/18/2020.Gtin: 00878953003986.Extrusion of the cylinders was reported.The ams700 device was visually inspected and functionally tested.No leak was found.The cylinders performed within specifications.The product analysis was unable to confirm the allegation of cylinder extrusion.Pump malfunction was reported.The ams700 momentary squeeze pump was visually inspected and functionally tested.No leak was found.The pump failed the inflation test and did not transfer a sufficient amount of fluid to fully inflate the cylinders.The deflation test results were out of specification, it took greater than 14 seconds to deflate from 20 psi to 4 psi.The specification is 14 seconds or less.The product analysis confirmed the allegation of pump malfunction.
 
Event Description
It was reported that due to the cylinder and pump breaking through the glans penis of cylinder and dimpled pump the patient had his inflatable penile prosthesis (ipp) cylinders and pump removed.The reservoir was plugged and remains implanted.It was further reported that the "cylinder's side at the glans penis damaged the tissue, so the cylinder extruded." the cylinder extruded out of the weak area.The extrusion occurred and the device stopped working 3 weeks ahead of surgery.The patient got well following this surgery.
 
Manufacturer Narrative
Pump model- 72404310 lot sn- (b)(4).Mfg date- 09/02/2015 exp date- 08/18/2020 gtin- (b)(4).Correction to b5 and h6: updated event description and coding.
 
Event Description
It was reported that due to the cylinder and pump breaking through the glans penis of cylinder and dimpled pump the patient had his inflatable penile prosthesis (ipp) cylinders and pump removed.The reservoir was plugged and remains implanted.It was further reported that the "cylinder's side at the glans penis damaged the tissue, so the cylinder extruded." the cylinder extruded out of the weak area.The extrusion occurred and the device stopped working 3 weeks ahead of surgery.The patient got well following this 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 Key9269171
MDR Text Key165234125
Report Number2183959-2019-67245
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953002682
UDI-Public00878953002682
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,Followup
Report Date 12/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date06/04/2019
Device Model Number72404011
Device Catalogue Number72404011
Device Lot Number886685002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2019
Date Manufacturer Received12/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age61 YR
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