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

Model Number	72401850
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while preparing the implant table, the scrub nurse and rep noticed a small hair in the cap of the keith needle holder.Another needle was used to complete the surgery.No patient injury or further device issues were reported.
Additional Manufacturer Narrative
Upon receipt of this inflatable penile prosthesis (ipp) accessory kit at our quality assurance laboratory, the returned components underwent a thorough analysis.The accessory kit was visually inspected and all components passed inspection.The foreign material (hair) was found in the sealed cap of the keith needle holder, confirming the reported clinical observations.Evidence from the product record review did not identify a potential product quality issue or new patient harm.Risk review and labeling review identified that the adverse event of foreign matter is a known risk of the device.
Event or Problem Description
It was reported that while preparing the implant table, the scrub nurse and rep noticed a small hair in the cap of the keith needle holder.Another needle was used to complete the surgery.No patient injury or further device issues were reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS ACCESSORY KIT
• Common Device Name: 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18535156
• Report Number: 2124215-2024-02382
• Device Sequence Number: 15378017
• Product Code: FHW
• UDI-Device Identifier: 00878953001135
• UDI-Public: 00878953001135
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72401850
• Device Catalogue Number: 72401850
• Device Lot Number: 1100394608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2023
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2023
• 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
• Patient Sex: Unknown