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

Model Number	72404291
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the hospital with an inflatable penile prosthesis (ipp) that was not functioning properly.At a later date, the cylinder and pump were explanted and replaced with a new cylinder and pump.Upon explant, a crack was found in the cylinder connecting tube.No patient complications were reported.
Event or Problem Description
It was reported that the patient presented to the hospital with an inflatable penile prosthesis (ipp) that was not functioning properly.At a later date, the cylinder and pump were explanted and replaced with a new cylinder and pump.Upon explant, a crack was found in the cylinder connecting tube.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt of the inflatable penile prosthesis (ipp) at our quality assurance laboratory, the returned components underwent a thorough analysis.Visual examination of one of the cylinders identified multiple leaks consistent with sharp instrument damage on one cylinder.The other cylinder presented a leak in the kink resistant tubing (krt) that was also consistent with sharp instrument damage.The pump krt had fatigued and was worn down to the filament, but the pump did not present any leaks.The pump did not pass the functional testing that was performed.Based on the information available, the pump did not operate within product specifications and could affect the functionality of the device; therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Additional Manufacturer Narrative
Upon receipt of this inflatable penile prosthesis (ipp) at our quality assurance laboratory, the returned components underwent a thorough analysis.Visual examination of one of the cylinders identified multiple leaks consistent with sharp instrument damage.The other cylinder had a leak in the kink resistant tubing (krt), also consistent with sharp instrument damage.The tubing had fatigued and was worn down to the filament, but the pump did not present any leaks and passed the functional testing that was performed.Based on the information available, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient presented to the hospital with an inflatable penile prosthesis (ipp) that was not functioning properly.At a later date, the cylinder and pump were explanted and replaced with a new cylinder and pump.Upon explant, a crack was found in the cylinder connecting tube.No patient complications were reported.
Event or Problem Description
It was reported that the patient presented to the hospital with an inflatable penile prosthesis (ipp) that was not functioning properly.At a later date, the cylinder and pump were explanted and replaced with a new cylinder and pump.Upon explant, a crack was found in the cylinder connecting tube.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt of the inflatable penile prosthesis (ipp) at our quality assurance laboratory, the returned components underwent a thorough analysis.Visual examination of one of the cylinders identified multiple leaks consistent with sharp instrument damage.The other cylinder presented a leak in the kink resistant tubing (krt) that was also consistent with sharp instrument damage.The pump krt had fatigued and was worn down to the filament, but the pump did not present any leaks and passed the functional testing that was performed.Based on the information available, a conclusion code of cause not established was assigned to this investigation.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15414754
• Report Number: 2124215-2022-35807
• Device Sequence Number: 6619314
• Product Code: FHW
• UDI-Device Identifier: 00878953003931
• UDI-Public: 00878953003931
• 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: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/21/2022

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: 01/26/2021
• Device Model Number: 72404291
• Device Catalogue Number: 72404291
• Device Lot Number: 119417003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 11/01/2022; 11/10/2022; 12/08/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 11/11/2022; 11/14/2022; 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PUMP LOT #146390001; PUMP LOT #146390001; PUMP LOT #146390001; PUMP LOT #146390001; RESERVOIR LOT #144010003; RESERVOIR LOT #144010003; RESERVOIR LOT #144010003; RESERVOIR LOT #144010003
• Outcome Attributed to Adverse Event: Hospitalization; Hospitalization; Required Intervention; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male