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

Model Number 720074-02

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

Same patient and surgery as mfr # 2183959-2020-04665.

Event Description

It was reported that the spectra penile prosthesis (spp) cylinders were not used because the cover broke.The physician took the cylinders from the box and attempted to implant them.On his first attempt to implant them the cover broke so the cylinders were replaced.Another pair of cylinders were used to complete the patient's surgery successfully.

Manufacturer Narrative

Device evaluation: the spectra cylinders were visually and functionally tested.Both cylinders had sharp instrument/tool damage to the outer tube, which resulted in a hole and exposed metal segments.Both cylinders passed the bend test with a force readout of less than 1390 grams.Product analysis was unable to confirm the reported events as sharp instrument was identified.The product record review indicated 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.Based on this investigation, the investigation conclusion code of "unintended use error caused or contributed to event" was chosen because the physician made an unintentional error that caused the event.Based on the results of this investigation, no escalation is required.Review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.

Event Description

It was reported that the spectra penile prosthesis (spp) cylinders were not used because the cover broke.The physician took the cylinders from the box and attempted to implant them.On his first attempt to implant them the cover broke so the cylinders were replaced.Another pair of cylinders were used to complete the patient's surgery successfully.

• 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: 10681751
• MDR Text Key: 211421906
• Report Number: 2183959-2020-04664
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005287
• UDI-Public: 00878953005287
• Combination Product (y/n): N
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

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: Lay User/Patient
• Device Expiration Date: 05/19/2024
• Device Model Number: 720074-02
• Device Catalogue Number: 720074-02
• Device Lot Number: 1000278659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 11/26/2020
• Patient Sequence Number: 1
• Patient Age: 41 YR