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

Model Number	72401850
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: based on the information available, boston scientific concludes that the cause that contributed to the reported event cannot be established as the product is not available for analysis.Device history record review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed however, there are several failure modes of the device that could lead to particulates within system, which include but are not limited to a defective components.Without a returned product available for analysis and based on this investigation a clear probable cause for the event cannot be established.Labeling review: 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.There is no objective evidence that the user did not properly handle or use the device according to the ams 700 instructions for use (ifu).Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that during preparation of the implant table prior to surgery, the scrub tech noticed a particle in the injectable saline that was designated for the implant preparation.The particle was removed and studied by the scrub tech, circulating nurse, and sales representative.The particle was believed to have been a piece of the 22 gauge hyponeedle cap that broke off.The injectable saline was then discarded and replaced.The syringes were replaced and the hyponeedles were flushed to removed any potential particles.No further resolution steps were necessary after this.There were no patient complications and the procedure was successfully completed.

• 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
• MDR Report Key: 12343761
• Report Number: 2124215-2021-24879
• Device Sequence Number: 16989992
• Product Code: FHW
• UDI-Device Identifier: 00878953001135
• UDI-Public: 00878953001135
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 08/19/2021

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 Expiration Date: 06/30/2026
• Device Model Number: 72401850
• Device Catalogue Number: 72401850
• Device Lot Number: 1000585065
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1