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

Model Number UNK-P-IPP

Device Problems Material Puncture/Hole (1504); Migration (4003)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Obstruction/Occlusion (2422)

Event Date 03/30/2022

Event Type  Injury  

Manufacturer Narrative

Event was previously reported under medwatch uf/importer report # (b)(4).

Event Description

It was reported that the patient presented to hospital emergency room with penile pain and what appeared to be a foreign body protruding from the meatus.The patient history reveals he had an inflatable penile prosthesis (ipp) placed at another facility approximately 14 years ago.The urology examination found the foreign body was one of the penile shaft segments that had eroded through the urethra wall causing urinary obstruction and leading to infection.A surgical removal was done where they found a rupture/breach of the parylene covering on the right side cylinder which was the side with erosion and protrusion into the urethrae occurred.At this time, the patient is still hospitalized and experiencing urinary retention.

Manufacturer Narrative

Event was previously reported under medwatch uf/importer report # (b)(4).There was no device available for analysis.The reported patient symptoms are known risk associated with implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported that the patient presented to hospital emergency room with penile pain and what appeared to be a foreign body protruding from the meatus.The patient history reveals he had an inflatable penile prosthesis (ipp) placed at another facility approximately 14 years ago.The urology examination found the foreign body was one of the penile shaft segments that had eroded through the urethra wall causing urinary obstruction and leading to infection.A surgical removal was done where they found a rupture/breach of the parylene covering on the right side cylinder which was the side with erosion and protrusion into the urethrae occurred.At this time, the patient is still hospitalized and experiencing urinary retention.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 14489723
• MDR Text Key: 292578276
• Report Number: 2124215-2022-17975
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-IPP
• Device Catalogue Number: UNK-P-IPP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Race: White