MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REAR TIP EXTENDER; PROSTHESIS, PENILE

Model Number	72404330
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: premarket/510(k) exceeded the character limit; the full numbers are: k090663, n970012.D2b: pro code (product code) exceeded the character limit; the full numbers are: fae, jcw.
Event or Problem Description
It was reported that during the preparation of an implantation of this inflatable penile prosthesis (ipp) stackable rtes were opened by the circulator and passed to the scrub technician, the packaging was not damaged prior to opening.The scrub tech prepped the ipp cylinders and dumped the rtes out onto the back table to attach them to the cylinders and noted a hair on one of the rtes.The hair was inside the packaging.As a result, the procedure was complete with another rte.The tech retained the contaminated rtes to show her manager, but no pictures were available.No patient complications reported.
Additional Manufacturer Narrative
G4: premarket/510(k) exceeded the character limit; the full numbers are: k090663, n970012.D2b: pro code (product code) exceeded the character limit; the full numbers are: fae, jcw.The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.A risk review was completed and confirmed that the event of foreign material present in device was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available the cause that contributed to the reported event cannot be established.Therefore, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that during the preparation of an implantation of this inflatable penile prosthesis (ipp) stackable rtes were opened by the circulator and passed to the scrub technician, the packaging was not damaged prior to opening.The scrub tech prepped the ipp cylinders and dumped the rtes out onto the back table to attach them to the cylinders and noted a hair on one of the rtes.The hair was inside the packaging.As a result, the procedure was complete with another rte.The tech retained the contaminated rtes to show her manager, but no pictures were available.No patient complications reported.

• Brand Name: REAR TIP EXTENDER
• Common Device Name: PROSTHESIS, PENILE
• 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: 23922901
• Report Number: 2124215-2025-93536
• Device Sequence Number: 9152497
• Product Code: N/A
• UDI-Device Identifier: 00878953004112
• UDI-Public: (01)00878953004112(17)300929(10)1100805875
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: 72404330
• Device Catalogue Number: 72404330
• Device Lot Number: 1100805875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 05/13/2026
• Date Device Manufactured: 09/30/2025
• 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 Age: 70 YR
• Patient Sex: Male