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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 72404014
Device Problems Mechanical Problem (1384); Material Puncture/Hole (1504)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/09/2021
Event Type  Injury  
Event Description
It was reported that the inflatable penile prosthesis (ipp) device was not working properly, so the patient visited the hospital a month before surgery.As a result of the examination, the implant was completely replaced at the discretion of the doctor due to a crack in the reservoir connecting tube.The cause of the connection tube crack has not been confirmed by the hospital.After this operation, the patient improved.
 
Event Description
It was reported that the inflatable penile prosthesis (ipp) device was not working properly, so the patient visited the hospital a month before surgery.As a result of the examination, the implant was completely replaced at the discretion of the doctor due to a crack in the reservoir connecting tube.The cause of the connection tube crack has not been confirmed by the hospital.After this operation, the patient improved.
 
Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes that the device was visually inspected, and the cylinder 1 had a leak in the kink resistant tubing (krt), and a hole was visually identified.This leak is identified as a result of sharp instrument damage, which is consistent with explant damage and considered a secondary failure.The tubing in cylinder 2 was not returned for analysis, however it was noted in cylinder 2 that the tube was cut down to the input sleeve junction.Both cylinders had wear at fold in cylinder body.Cylinder 1 was not functionally tested due to hole identified, and cylinder 2 was pressure tested and performed within specification.Based on the observed cut tubing and the cylinder performed within specification, the reported allegation is unable to be confirmed.Device history review (dhr): the device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Device technical analysis: visual inspection showed that the cylinder 1 had a leak in the kink resistant tubing (krt), and a hole was visually identified.This leak is identified as a result of sharp instrument damage, which is consistent with explant damage and considered a secondary failure.The tubing in cylinder 2 was not returned for analysis, however it was noted in cylinder 2 that the tube was cut down to the input sleeve junction.Both cylinders had wear at fold in cylinder body.Cylinder 1 was not functionally tested due to hole identified, and cylinder 2 was pressure tested and performed within specification.Investigation conclusion: based on this investigation, the investigation conclusion code of cause not established was chosen because the tubing was not returned for analysis; however, the most probable cause could not be confirmed.Based on the results of this investigation, no escalation is required.
 
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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 Key11227886
MDR Text Key228604696
Report Number2183959-2021-00132
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953002712
UDI-Public00878953002712
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,o
Type of Report Initial,Followup
Report Date 03/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/12/2023
Device Model Number72404014
Device Catalogue Number72404014
Device Lot Number1000036545
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2021
Initial Date Manufacturer Received 01/11/2021
Initial Date FDA Received01/25/2021
Supplement Dates Manufacturer Received02/12/2021
Supplement Dates FDA Received03/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
7240182-01/1000057048; 7240182-01/1000057048; 72404310/188587010; 72404310/188587010; 7240182-01/1000057048.; 72404310/188587010.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age63 YR
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