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

Model Number	72404274
Medical Device Problem Codes	Deflation Problem (1149); Fluid/Blood Leak (1250); Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number 72404310, serial number (b)(4), batch/lot number 1000125699, gtin (b)(4), description pump ms, expiration date 06/25/2023.Manufacturer date 06/26/2018.Model number/catalog number 72404161, serial number (b)(4), batch/lot number 1000175745, gtin (b)(4), model/catalog description reservoir 65ml pc, expiration date 10/16/2023.Manufacturer date 10/17/2018.
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis removed due to cylinder tear.A new inflatable penile prosthesis consisting of cylinders, pump, and reservoir were implanted.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.Additional information received indicated the patient had trouble inflating or deflating the device due to a lack of saline inside the device.It was indicated that the physician may have hit the surface of the cylinder by mistake.The patient got well following the revision surgery.
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis removed due to cylinder tear.A new inflatable penile prosthesis consisting of cylinders, pump, and reservoir were implanted.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.Additional information received indicated the patient had trouble inflating or deflating the device due to a lack of saline inside the device.It was indicated that the physician may have hit the surface of the cylinder by mistake.The patient got well following the revision surgery.
Additional Manufacturer Narrative
The complaint components were returned and analyzed.The reported allegations of cylinder tear and fluid loss and inflation issue were confirmed via product analysis of the cylinders and reservoir.Functional testing revealed a leak in the cylinder body of cylinder 2 due to interaction with a sharp instrument.Functional testing of the pump confirmed a failure that may have contributed to the reported complaint.Functional testing of the reservoir did not confirm leaks.No escalation to ncep, capa, or scar is required.Model number/catalog number 72404310 serial number (b)(4) batch/lot number 1000125699 gtin 878953003986 description pump ms expiration date 06/25/2023 manufacturer date 06/26/2018 model number/catalog number 72404161 serial number (b)(4) batch/lot number 1000175745 gtin 878953003238 model/catalog description reservoir 65ml pc expiration date 10/16/2023 manufacturer date 10/17/2018.

• Brand Name: AMS INFLATABLE 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: 8663515
• Report Number: 2183959-2019-63632
• Device Sequence Number: 2182927
• Product Code: FHW
• UDI-Device Identifier: 00878953003818
• UDI-Public: 00878953003818
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 07/26/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2022
• Device Model Number: 72404274
• Device Catalogue Number: 72404274
• Device Lot Number: 0167597007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR