MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RTE SNAPCONE; PROSTHESIS PENIS INFLATABLE| PROSTHESIS PENILE

Model Number	72404322
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned for evaluation.
Event or Problem Description
The patient experienced unspecified issues with an inflatable penile prosthesis (ipp).Only the ipp rear tip extenders (rte) were used.It was further reported that the reason for this surgery was due to the distal tip of the cylinder in the left corporal body was longer then the cylinder in the right corporal body.The patient did not like this discrepancy and he wanted the cylinder even in the glans.A 2 cm rte was removed from the left cylinder and a.5 cm rte was placed back in the left cylinder.The patient status following this surgery was that there was no patient issue and the implant was functioning as designed.

• Brand Name: RTE SNAPCONE
• Common Device Name: PROSTHESIS PENIS INFLATABLE| PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9135422
• Report Number: 2183959-2019-66471
• Device Sequence Number: 11399752
• Product Code: FHW
• UDI-Device Identifier: 00878953004068
• UDI-Public: 00878953004068
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2019

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: 04/02/2024
• Device Model Number: 72404322
• Device Catalogue Number: 72404322
• Device Lot Number: 1000256485
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 09/30/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR