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

Model Number 720074-03

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2020

Event Type  malfunction  

Event Description

It was reported that the patient had a removal of his inflatable penile prosthesis (ipp) due to scrotal pain.The ipp was replaced with a spectra malleable penile prosthesis (spp).During the case, when the doctor was about to implant the spp on the right side of the corpora, he noticed that there was missing part/piece of coating on the outside of the device (visible pieces of metal inside).Another device with different lot number was used to complete the procedure (one lot number on one side of the penis and another lot number on the other side).One of the device/rod (720074-03/120414004 left cylinder) was defective, while (720074-03/ 1000132285 right cylinder) was not defective.The procedure was completed and no patient complications were reported in relation to this event.

Event Description

It was reported that the patient had a removal of his inflatable penile prosthesis (ipp) due to scrotal pain.The ipp was replaced with a spectra malleable penile prosthesis (spp).During the case, when the doctor was about to implant the spp on the right side of the corpora, he noticed that there was missing part/piece of coating on the outside of the device (visible pieces of metal inside).Another device with different lot number was used to complete the procedure (one lot number on one side of the penis and another lot number on the other side).One of the device/rod (720074-03/120414004 left cylinder) was defective, while (720074-03/ 1000132285 right cylinder) was not defective.The procedure was completed and no patient complications were reported in relation to this event.

Manufacturer Narrative

The complaint component was returned and analyzed, and the reported allegation was confirmed via product analysis.Product analysis confirmed the reported events based on the identification of exposed metal segments in the cylinder due to sharp instrument damage to the sheath.Based on the manufacturing record review and visual inspection, this damage was concluded to be attributed to unintentional damage during the implant procedure.The product record review indicated that the reported events do not represent an unanticipated event.Review of the manufacturing documentation confirmed all required in-process and final inspections and testing were completed.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9842617
• MDR Text Key: 183751629
• Report Number: 2183959-2020-01320
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005294
• UDI-Public: 00878953005294
• Combination Product (y/n): N
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2021
• Device Model Number: 720074-03
• Device Catalogue Number: 720074-03
• Device Lot Number: 0120414004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 03/27/2020
• Patient Sequence Number: 1
• Patient Age: 59 YR