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

Model Number M00550601

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.(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 device was used during a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the gauge needle did not go up when pressure was applied.The procedure was completed with another alliance inflation syringe.There have been no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: problem code 1184 captures the reportable issue of gauge reading inaccurate.Block h10: 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.Additional information: block d4 (lot number and expiry date) and block h4 (manufacturing date).

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe device was used during a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the gauge needle did not go up when pressure was applied.The procedure was completed with another alliance inflation syringe.There have been no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: problem code 1184 captures the reportable issue of gauge reading inaccurate.Block h10: investigation results a visual examination of the returned complaint device revealed that the gauge needle was in its original position, and was indicating 0 atm.It was also noted that inside the y-adaptor there were residues.Functional evaluation was performed, and the device was pressurized using 35 ml of sterile water; no leak was observed.The device was able to hold the pressure but gauge was not responding to the presure applied.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.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.

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe device was used during a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the gauge needle did not go up when pressure was applied.The procedure was completed with another alliance inflation syringe.There have been no patient complications reported as a result of this event.

• Brand Name: ALLIANCE II
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 00 boston scientific way; marlborough MA 01752
• MDR Report Key: 9512152
• MDR Text Key: 189846836
• Report Number: 3005099803-2019-06158
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729129332
• UDI-Public: 08714729129332
• 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,Followup
• Report Date: 03/05/2020

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: 05/02/2021
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0023737473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/08/2020; 02/11/2020
• Supplement Dates FDA Received: 02/04/2020; 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1