MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENCORE 26; SYRINGE, BALLOON INFLATION

Device Problems Device Contaminated During Manufacture or Shipping (2969); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2022

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the suspected upn and lot number; therefore, the manufacture date and expiration date are unknown.(b)(4).The returned encore 26 inflation device was analyzed, and a visual evaluation noted that the gauge needle was at 0 atm when received.Additionally, white stains were also observed outside of the case and the gauge.Functional evaluation was performed, and the plunger was able to be actioned back and forth smoothly.A pressure damp test, vacuum test, side load test, gauge accuracy test and device locking mechanism test were also performed, and the device passed all the test without problems.No other problems with the device were noted.The reported event of handle would not turn was not confirmed.Investigation found that the plunger was able to be actioned back and forth smoothly, and the device past all the functional tests.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that an encore 26 inflation device was used in the ureter during a ureter dilation procedure performed on (b)(6) 2022.During preparation, it was noticed that the handle of the device would not turn and could not be used.The procedure was completed with another encore 26 inflation device.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of white stains were observed outside of the case handle and the gauge.Please see block h10 for full investigation details.

• Brand Name: ENCORE 26
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15658769
• MDR Text Key: 307158796
• Report Number: 3005099803-2022-06111
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1