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

Model Number	72403872
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Deformity/ Disfigurement (2360)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical procedure the physician withdrew the extension body(rear tip extender) rte due to a measurement issue.The device was found that the two sides were not the same length, so the physician withdrew the extension body.A patient outcome of stable was reported.Additional information received that the physician was unable to insert the cylinder at one side.A 16cm cylinder and a 1cm rte remain implanted.The device will be returned for analysis.Additional information received that during installation of the rte, it was found that one side of the penis was bent, causing asymmetry between the two sides.After several attempts, the result was not satisfactory, and the penis was finally removed.
Event or Problem Description
It was reported that during a surgical procedure the physician withdrew the extension body(rear tip extender) rte due to a measurement issue.The device was found that the two sides were not the same length, so the physician withdrew the extension body.A patient outcome of stable was reported.Additional information received that the physician was unable to insert the cylinder at one side.A 16cm cylinder and a 1cm rte remain implanted.The device will be returned for analysis.Additional information received that during installation of the rte, it was found that one side of the penis was bent, causing asymmetry between the two sides.After several attempts, the result was not satisfactory, and the penis was finally removed.
Additional Manufacturer Narrative
Additional information received that initially, the term penis was used for the cylinder component.The cylinders were deflected slightly after the cylinders were implanted.Once the rte was removed the cylinders looked good.An allegation related to a measurement issue was reported.Five sets of rear tip extenders returned (3cm, 2cm, 1.5cm, 1cm, 0.5cm).All rear tip extenders were measured; no abnormalities were identified.Product analysis was unable to confirm the reported events.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.Based on this investigation, the investigation conclusion code of known inherent risk of device was chosen because a product malfunction related to the reported events was not identified and the adverse event of penile curvature is included in the product labeling and hazard analysis.Based on the results of this investigation, no escalation is required.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS KIT
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9918944
• Report Number: 2183959-2020-01828
• Device Sequence Number: 2789372
• Product Code: FHW
• UDI-Device Identifier: 00878953002408
• UDI-Public: 00878953002408
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/22/2024
• Device Model Number: 72403872
• Device Catalogue Number: 72403872
• Device Lot Number: 1000265961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR