MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS AMBICOR PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

Model Number	72401452
Medical Device Problem Codes	Degraded (1153); Defective Device (2588)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a revision of an inflatable penile prosthesis(ipp) device due to a damaged cylinder.A patient outcome was not reported.
Additional Manufacturer Narrative
Additional information received that after surgery, the patient is normal.The old ipp had a balloon on one of the cylinders.
Event or Problem Description
It was reported that the patient experienced a revision of an inflatable penile prosthesis(ipp) device due to a damaged cylinder.A patient outcome was not reported.
Additional Manufacturer Narrative
Additional information b5, d1, d4.Device analysis: an allegation of a damaged cylinder was reported.The ambicor cylinders, pump and tubing were visually inspected.A bulge was identified in one of the cylinders along with broken fabric.A leak was found in the other cylinder that was considered a secondary failure due to being consistent with explant damage.No other device malfunction was found.Product analysis concluded the identified bulge in one of the cylinders confirmed the reported allegation of cylinder degradation.Visual inspection of the ambicor cylinders, pump and tubing confirmed the reported allegation of a damaged cylinder.A bulge was identified in one of the cylinders along with broken fabric.Product analysis therefore concluded cylinder bulging as the most probable cause of the event, as the bulging aligns with the report of a balloon on one of the cylinders.The product record review confirmed the reported events do not represent an unanticipated event nor did the device fail to meet applicable product specifications prior to shipment from boston scientific.An investigation conclusion code of cause traced to component failure was chosen, as the reported events could be traced to cylinder bulging through product investigation.The product analysis results and event report provided no objective evidence that would warrant further escalation.
Event or Problem Description
It was reported that the patient experienced a revision of an inflatable penile prosthesis(ipp) device due to a damaged cylinder.A patient outcome was not reported.Additional information received that the revision was actually for an ambicor penile prosthesis(app).An inflatable penile prosthesis(ipp) device was implanted.

• Brand Name: AMS AMBICOR PENILE PROSTHESIS
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9417481
• Report Number: 2183959-2019-67937
• Device Sequence Number: 13574278
• Product Code: FHW
• UDI-Device Identifier: 00878953003481
• UDI-Public: 00878953003481
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/04/2018
• Device Model Number: 72401452
• Device Catalogue Number: 72401452
• Device Lot Number: 813960004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 12/24/2019; 03/19/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/16/2020; 03/25/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 58 YR