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 No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 020 as no event date was reported.(b)(4).Investigation results: visual examination of the returned complaint device found that the needle was indicating 0 atm.Functional evaluation was performed, and the device was pressurized using 35 ml of sterile water for 30 seconds; no leak was observed.However, the needle of the gauge did not move and remained in vac position.Based on the available information, it is most probable that the manner in which the device was handled and manipulated may have caused the encountered failure, as applying excessive pressure to the device and/or excessive manipulation without enough care during the procedure could induce the defects found in this device.However, since no specific failure was reported, the more probable cause could not be established due to lack of information.Therefore, the most probable root cause is cause not established.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

Boston scientific corporation received an unauthorized return of an alliance inflation syringe device.It was found that the gauge needle did not move.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: ALLIANCE II
• 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: 10106623
• MDR Text Key: 194328192
• Report Number: 3005099803-2020-02082
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729746737
• UDI-Public: 08714729746737
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2020

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: 08/05/2021
• Device Model Number: M00550600
• Device Catalogue Number: 5060-05S
• Device Lot Number: 0024219806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1