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

Model Number	720074-02
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had the spectra penile prosthesis removed due to pain.A new cxr inflatable penile prosthesis.Following the surgery, the event resolved.
Event or Problem Description
It was reported that the patient had the spectra penile prosthesis removed due to pain.A new cxr inflatable penile prosthesis.Following the surgery, the event resolved.
Additional Manufacturer Narrative
Corrected data b5 event description: investigation summary: with all the available information, boston scientific concludes, based on analysis results, the cause that contributed to the pain issue 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.Review of the manufacturing records found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.Device technical analysis: upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The spectra penile prosthesis (spp) cylinders were visually inspected, microscope examined and functionally tested.Both cylinders had sharp instrument/tool damage to the outer tube, which resulted in a hole and exposed metal segments.This damage is consistent with explant damage.Both cylinders were functionally tested and 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 review of the labeling confirmed the reported adverse events of pain 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.Investigation conclusion: based on this investigation a clear probable cause for the event was established; therefore, the investigation conclusion code of known inherent risk of device was chosen, as pain is included in the product labeling and hazard analysis.
Event or Problem Description
It was reported that the patient had the spectra penile prosthesis removed due to pain.A new cxr 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 13151483
• Report Number: 2124215-2021-39229
• Device Sequence Number: 3979105
• Product Code: FAE
• UDI-Device Identifier: 00878953005287
• UDI-Public: 00878953005287
• 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: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2022

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: Lay User/Patient
• Device Expiration Date: 02/01/2024
• Device Model Number: 720074-02
• Device Catalogue Number: 720074-02
• Device Lot Number: 1000226207
• 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: 12/07/2021
• Supplement Date Received by Manufacturer: 12/07/2021; 03/17/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 01/05/2022; 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male