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

Model Number M00566670

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

Block d4.The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.It was reported that the device was not used past its expiry date.Block h6: imdrf device code a0902 captures the reportable event of reading inaccurate.

Event Description

It was reported to boston scientific corporation that an encore 26 inflation device was (b)(6) 2023.During the procedure, the pressure memory of the device was not working at all.Since it was possible to apply pressure, the procedure was completed with the original device while checking the balloon diameter under fluoroscopy.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.It was reported that the device was not used past its expiry date.Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurate.Block h10: investigation results the returned encore 26 inflation device was analyzed, and a visual examination found that the gauge needle was at 0 atm when received.The device does not have visual defects.Functional analysis was performed, and the pressure damping test was performed to ensure the unit falls from 13 atm to 0 atm within 1 second.The unit passed the test.Vacuum test was performed, the unit was primed with 5 ml of water before withdrawing the plunger to create a vacuum.There was no bubble leakage.Side load test was performed, involved applying a load of 3.5 positive or negative 0.1 kg to the proximal end of the handle.The unit pass if the unit maintains a vacuum in this position.The unit passed the test.Gauge accuracy test was performed, at 13 atm, 26 atm & 0 atm to assess the accuracy of the gauge under pressurization.The unit passed the test.The unit passed all functional tests without problems.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of gauge reading inaccurate was not confirmed.During product analysis no problems could be found that can be related to this problem.The device could perform all the functional testing and the gauge was giving an accurate reading which confirms that the gauge was working in a conformance condition.Therefore, the most probable root cause is no problem detected.

Event Description

It was reported to boston scientific corporation that an encore 26 inflation device was used in the duodenum during a duodenal balloon dilatation procedure performed on (b)(6)2023.During the procedure, the pressure memory of the device was not working at all.Since it was possible to apply pressure, the procedure was completed with the original device while checking the balloon diameter under fluoroscopy.There were no patient complications reported as a result of this event.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18048676
• MDR Text Key: 327145858
• Report Number: 3005099803-2023-05896
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729755241
• UDI-Public: 08714729755241
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

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
• Device Model Number: M00566670
• Device Catalogue Number: 6667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 12/04/2023
• 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