MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALLIANCE II; SYRINGE, BALLOON INFLATION

Model Number M00550600

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 04/02/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe was used during a procedure performed on (b)(6) 2021.During the procedure, it was noticed that when the manometer of the alliance insufflation syringe presented malfunction.The procedure was completed with another alliance inflation syringe.No patient complications have been reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe was used during a procedure performed on (b)(6) 2021.During the procedure, it was noticed that when the manometer of the alliance insufflation syringe presented malfunction.The procedure was completed with another alliance inflation syringe.No patient complications have been reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: problem code a0902 captures the reportable event of gauge reading inaccurate.Block h10: investigation results: a visual examination of the returned complaint device revealed that the gauge needle was out of range when received.Functional evaluation was performed, pressurize of the device was not tested due to the gauge needle was out of range; no leak was observed.Microscopic analysis was performed, it was noted that the gauge had a hit inside of it.Based on the available information, the device did not have leaks nevertheless the gauge had a hit inside of it which probably induce that the gauge needle was out of range during the procedure.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: ALLIANCE II
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11738717
• MDR Text Key: 248179781
• Report Number: 3005099803-2021-01917
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729746737
• UDI-Public: 08714729746737
• Combination Product (y/n): N
• PMA/PMN Number: K922573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

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 Expiration Date: 02/02/2022
• Device Model Number: M00550600
• Device Catalogue Number: 5060-05S
• Device Lot Number: 0025144548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Initial Date Manufacturer Received: 04/05/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 09/23/2021
• Patient Sequence Number: 1
• Patient Age: 26 YR