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

Model Number	UNK-P-SPP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an original spectra penile prosthesis (spp) implant procedure the patient felt pain leading to the device being removed and the procedure aborted.The patient had been sedated when the implant was cancelled.There were no device malfunctions associated with the removed device.The patient did not experience additional adverse events and was good following the procedure.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes that the reported allegation of pain could not be confirmed through product analysis of the returned device.However, the reported patient symptom is a known risk associated with spectra procedures and is noted as such in the device instructions for use.Dhr review: a dhr and ship history cannot be performed as the serial/lot number for this component was not available.Technical analysis: upon receipt at our post market quality assurance laboratory, this spectra penile prosthesis (spp) was thoroughly analyzed.Visual and microscopical testing of the cylinders identified a that the rear tip had been trimmed or shaven down.Both cylinders also had sharp instrument damage resulting in a hole and exposed metal segments in the front tip.This damage was consistent with explant.Upon functional testing, both cylinders passed the bend test with a force readout of less than 1390 grams; therefore, performing within specification.Labeling review: there is no objective evidence that the user did not properly handle or use the device according to the spectra instructions for use (ifu).The spectra ifu lists pain as a potential adverse event associated with implant of this device.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.Section d was updated as the returned device did not match the initially reported device.Corrected fields: d4: model number, d4: lot number, d4: catalog number, d4: expiration date, d4: unique identifier (udi).
Event or Problem Description
It was reported that during an original spectra penile prosthesis (spp) implant procedure the patient felt pain leading to the device being removed and the procedure aborted.The patient had been sedated when the implant was cancelled.There were no device malfunctions associated with the removed device.The patient did not experience additional adverse events and was good following the procedure.

• 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: 12211358
• Report Number: 2124215-2021-20691
• Device Sequence Number: 17021499
• 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: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2025
• Device Model Number: UNK-P-SPP
• Device Catalogue Number: UNK-P-SPP
• Device Lot Number: 1000415743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 09/24/2021
• 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: Other
• Patient Age: 65 YR