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

Model Number 72404310

Device Problems Collapse (1099); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2020

Event Type  Injury  

Event Description

It was reported that due to a dimpled pump the patient had his inflatable penile prosthesis (ipp) pump explanted.It was explained that the patient was seen by his physician and testing showed that when the pump was pressed it dimpled.The physician and nurses tried several times following known procedures in the hospital, but the device would not work as expected.The directions for using the pump was re-educated to the patient, and it was tested several times after implant to assure a working device.The patient got better after this operation.

Event Description

It was reported that due to a dimpled pump the patient had his inflatable penile prosthesis (ipp) pump explanted.It was explained that the patient was seen by his physician and testing showed that when the pump was pressed it dimpled.The physician and nurses tried several times following known procedures in the hospital, but the device would not work as expected.The patient was re-implanted with a different pump.The directions for using the pump was re-educated to the patient, and it was tested several times after implant to assure a working device.The patient got better after this operation.

Manufacturer Narrative

Changes made to this report.Describe event or problem device analysis, evaluation method codes, evaluation results and conclusion.Upon receipt at our post market quality assurance laboratory, the ams 700 momentary squeeze (ms) pump was visually inspected, and no leaks were found.The spring inside the pump observed to be non-concentric and the implant instructions stated that the coils of the poppet spring should not be crossed or misaligned.It was unknown when the misaligned poppet spring had occurred.The pump was functionally tested and did not pass the inflation test and activation test.He device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Product analysis confirmed the reported allegations pump collapse.

• 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 Key: 10674012
• MDR Text Key: 211226853
• Report Number: 2183959-2020-04629
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003986
• UDI-Public: 00878953003986
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 1000271165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES #86562
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR