MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MS PUMP; PROSTHESIS, PENIS, INFLATABLE

Model Number	72404209
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working properly.As a result of the inspection, it was confirmed that there was a crack in the left cylinder connecting tube.The pump was explanted and replaced.No patient complications reported.
Additional Manufacturer Narrative
Correction to field d1.Brand name.Correction to fields d4.Model number, lot number, catalog number, expiration date and unique identifier (udi) #.Correction to field c2/d10.Concomitant product/therapy.Correction to field device h4.Manufacture date.Upon receipt at our quality assurance laboratory, the component of this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was microscopically inspected, and leak tested.The microscope test revealed that the pump had contamination (bodily fluid).The pump tubing was cut down to the pump block; the tubing was not returned for analysis.The pump passed the leak test.Product analysis was unable to confirm the reported device allegation.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working properly.As a result of the inspection, it was confirmed that there was a crack in the left cylinder connecting tube.The pump was explanted and replaced.No patient complications reported.

• Brand Name: MS PUMP
• Common Device Name: PROSTHESIS, PENIS, INFLATABLE
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21058496
• Report Number: 2124215-2024-82158
• Device Sequence Number: 18306948
• Product Code: JCW
• UDI-Device Identifier: 00878953003351
• UDI-Public: 00878953003351
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: 05/26/2025
• Device Model Number: 72404209
• Device Catalogue Number: 72404209
• Device Lot Number: 1100306232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOT#: 1100293040 UPN: 72404273 CX; LOT#: 1100303372 UPN: 72404161 RESERVOIR; LOT#: 1100303372 UPN: 72404161 RESERVOIR; LOT#: 1100306232 UPN: 72404310 PUMP
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male