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

Model Number	720054-02
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had the spectra penile prosthesis left 9.5mm x 16cm cylinder replaced with a 12mm x 16cm cylinder as the front part of the penis was bent while during sex with a partner.Following the revision surgery, the patient was stable, improved and the event resolved.
Event or Problem Description
It was reported that the patient had the spectra penile prosthesis left 9.5mm x 16cm cylinder replaced with a 12mm x 16cm cylinder as the front part of the penis was bent while during sex with a partner.Following the revision surgery, the patient was stable, improved and the event resolved.
Additional Manufacturer Narrative
Investigation summary: an allegation related to cylinder has diameter too small was reported.The cylinder performed within specification.Product analysis was unable to confirm the reported event.Device history record (dhr): review of the manufacturing records for batch 1000237405 was completed and found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.Labeling review: review of the labeling confirmed the reported adverse events of device sizing is included in the product labeling.There is no objective evidence that the user did not properly handle or use the device according to the spectra ifu.Additionally, the reported events do not contain an allegation against the labeling.Device technical analysis: the spectra cylinder was visually and functionally tested; no evidence of any damage was identified.Cylinder passed the bend test with a force readout of less than 1390 grams.The cylinder therefore performed within specification.Product analysis was unable to confirm the reported event.Investigation conclusion: based on this investigation, the investigation conclusion code of no problem detected was chosen because the reported events could not be confirmed or substantiated through investigation.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Common Device Name: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 11293748
• Report Number: 2183959-2021-00320
• Device Sequence Number: 3498834
• 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: 2020
• 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): 03/12/2021

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: 02/25/2024
• Device Model Number: 720054-02
• Device Catalogue Number: 720054-02
• Device Lot Number: 1000237405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR