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

Model Number	72401850
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter could not be placed during the procedure; therefore, the procedure was cancelled.It was noted that the patient had already been administered feneral anesthesia.There were no device issues and no patient complications.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this ams 700 accessory kit underwent a thorough analysis.Visual inspection identified there were two straight window quick connectors (wqc), three right angle wqc, three straight suture-tie connectors, two right angle suture-tie connectors, eight collets, one collet holder, one 22g blunt tip needle, four 13 cm lengths of tubing and 1 tubing plug.All these components passed visual inspection.Additionally, it was noted that one straight wqc, one 22g blunt tip needle, two 15g blunt tip needles, two keith needles and one proximal tool were not returned for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available no fault conditions could be identified.A conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that the catheter could not be placed during the procedure; therefore, the procedure was cancelled.It was noted that the patient had already been administered general anesthesia.There were no device issues and no patient complications.This event is being reported for the procedure aborted after patient sedation with general anesthesia.

• 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16993760
• Report Number: 2124215-2023-25908
• Device Sequence Number: 17846147
• Product Code: FHW
• UDI-Device Identifier: 00878953001135
• UDI-Public: 00878953001135
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 07/10/2023

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: 1100284791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• 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