MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS PENILE

Model Number	720054-02
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had the spectra penile prosthesis removed as it was bent.A new inflatable penile prosthesis was implanted.Following the surgery, the event resolved.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes, based on analysis results, the cause that contributed to the cylinder bend was not confirmed.Device history record review (dhr): the device history record review (dhr) confirmed that the device met all material, assembly and performance specifications.A risk review confirmed that the event is accounted for in the risk documentation.Device technical analysis: the spectra cylinders were visually inspected, microscope examined and functionally tested.Both cylinders had sharp instrument/tool damage to the outer tube in cylinder bodies, which resulted in a hole and exposed metal segments.This damage is consistent with explant damage.Both cylinders passed the bend test with a force readout of less than 1390 grams.The cylinders therefore performed within specification.Product analysis was unable to confirm the reported events.Labeling review: a labeling review found no evidence of device off-label use or failure to follow instructions.Investigation conclusion: based on this investigation a clear probable cause for the event was not established; therefore, the conclusion code of cause not established was chosen because the cylinder sharp instrument/tool damage that was identified was consistent with explant damage.Therefore, the most probable cause could not be confirmed.
Event or Problem Description
It was reported that the patient had the spectra penile prosthesis removed as it was bent.A new inflatable penile prosthesis was implanted.Following the surgery, the event resolved.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Common Device Name: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12297401
• Report Number: 2124215-2021-24066
• Device Sequence Number: 3590279
• Product Code: FAE
• UDI-Device Identifier: 00878953005218
• UDI-Public: 00878953005218
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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: 03/18/2025
• Device Model Number: 720054-02
• Device Catalogue Number: 720054-02
• Device Lot Number: 1000415661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 09/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR