MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

Model Number	72404268
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Incontinence (1928); No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
System components: reservoir, model- 72404155, lot sn- (b)(4), mfg date- 10/01/2018, exp date- 09/30/2020, gtin- (b)(4).
Event or Problem Description
It was reported that the patient experienced an extrusion of inflatable penile prosthesis(ipp) cylinder due to the extrusion of the cylinder by the urethral meatus.The patient could still urinate without difficulty and will be scheduled for an explanation of the prosthesis.A stable patient condition was reported.
Additional Manufacturer Narrative
Additional information received that the health care facility associated with the event is medihelp.System components reservoir model- 72404155 lot sn- (b)(4) mfg date- 10/01/2018 exp date- 09/30/2020 gtin- 00878953003207.
Event or Problem Description
It was reported that the patient experienced an extrusion of inflatable penile prosthesis(ipp) cylinder due to the extrusion of the cylinder by the urethral meatus.The patient could still urinate without difficulty and will be scheduled for an explanation of the prosthesis.A stable patient condition was reported.
Event or Problem Description
It was reported that the patient experienced an extrusion of inflatable penile prosthesis(ipp) cylinder due to the extrusion of the cylinder by the urethral meatus.The patient could still urinate without difficulty and will be scheduled for an explanation of the prosthesis.A stable patient condition was reported.
Additional Manufacturer Narrative
Additional information received that the device was explanted when the complication occurred.The tip of the cylinder was visible in the meatus when the patient came to a revision appointment with urinary symptoms.The patient reported difficulties in the urinary stream.Significant voiding symptoms after removal of the urethral catheter were not reported but the patient is recovering from his inflammatory process.
Additional Manufacturer Narrative
Extrusion was reported.The ams700 device was visually inspected and functionally tested.There was a leak in both cylinders that was the result of sharp instrument damage consistent with explant damage.Damage incurred during the explant process would not have contributed to the failure responsible for device explant.The pump failed the 8 lb.Activation test.The pump required more than 8 lbs.Of force to activate.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 container 22798723 found no evidence that the device failed to meet applicable product specifications prior to shipment from bsc.Ship history, labeling review and risk review not required per (b)(4) wi cis product investigation.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered known inherent risk of device.This complaint investigation conclusion code is utilized when the reported adverse event known and documented in the labeling (including both short or long term known complications or adverse reactions).While we are unable to confirm patient symptoms, the reported allegation of extrusion is a known inherent risk of the device included in our labelling.Based on the results of this investigation, no escalation is necessary.System components: reservoir: model: 72404155, lot sn: (b)(4), mfg date: 10/01/2018, exp date: 09/30/2020, gtin: (b)(4).
Event or Problem Description
It was reported that the patient experienced an extrusion of inflatable penile prosthesis(ipp) cylinder due to the extrusion of the cylinder by the urethral meatus.The patient could still urinate without difficulty and will be scheduled for an explanation of the prosthesis.A stable patient condition was reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8679190
• Report Number: 2183959-2019-63798
• Device Sequence Number: 16629533
• Product Code: FHW
• UDI-Device Identifier: 00878953003764
• UDI-Public: 00878953003764
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/06/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/18/2020
• Device Model Number: 72404268
• Device Catalogue Number: 72404268
• Device Lot Number: 1000179879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 06/28/2019; 08/07/2019; 09/03/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 06/28/2019; 08/08/2019; 09/06/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 32 YR