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

Model Number	72401110
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The device performance allegation can be confirmed.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 had a surgical procedure to replace an inflatable penile prosthesis (ipp) since the device did not work.A crack was found in the pump connector tube, and the pump was replaced.The cause of the pump connecting tube crack is unknown.After the procedure, the patient improved and the patient outcome was reported stable.
Event or Problem Description
It was reported that the patient had a surgical procedure to replace an inflatable penile prosthesis (ipp) since the device did not work.A crack was found in the pump connector tube, and the pump was replaced.The cause of the pump connecting tube crack is unknown.After the procedure, the patient improved and the patient outcome was reported stable.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes, based on analysis results, product analysis was unable to confirm the reported events related to the pump connecting tube crack as the tubing was not returned for analysis.Device history record review (dhr): the device history record review (dhr) confirmed that the device met all material, assembly and performance specifications prior to shipment from boston scientific.Additionally, potential emerging trends are captured as part of the post market signal evaluation and escalation process device technical analysis: upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The ipp cxm inflate/deflate pump was leak tested and visually inspected and examined using a microscope.No tubing was return for the analysis.The pump kink resistant tubing (krt) was identified to be cut down closer to the pump restrain relief krt junction.The pump krt was worn down to the filament.The outer layer of pump bulb was worn that was a result of wear against the pump strain relief and krt junction.No leaks were found.Product analysis was unable to confirm the reported events.Labeling review: a labeling review found no evidence of device off-label use or failure to follow instructions.The reported events also do not contain an allegation against the labeling.Investigation conclusion: based on this investigation a clear probable cause for the event was not established; therefore, the investigation conclusion code of cause not established was chosen because the tubing was not return for analysis.Therefore, the most probable cause could not be confirmed.

• 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 ; 4089353452
• MDR Report Key: 13491690
• Report Number: 2124215-2022-04010
• Device Sequence Number: 11736292
• 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: 2011
• 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
• Report Date (Section B): 03/28/2022

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: 01/13/2016
• Device Model Number: 72401110
• Device Catalogue Number: 72401110
• Device Lot Number: 693486003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2011
• 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: CYLINDERS MODEL # 72404291LOT # 126697003.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male