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

Model Number M00550601

Device Problems Display or Visual Feedback Problem (1184); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.(b)(6).(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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

Note: this report pertains to two cre pro gi wireguided dilation balloons and two alliance inflation syringes used during the same patient and procedure.It was reported to boston scientific corporation that two cre pro gi wireguided dilation balloons and two alliance inflation syringes were used during a procedure performed on an unknown date.According to the complainant, during the procedure, it was noticed that the balloon seemed to be inflated on the fluoroscopy; however, the needle of the syringe did not move at all.Reportedly, a second cre pro gi wireguided dilation balloon was used but the issue was not resolved.Then, a second alliance inflation syringe was used but the issue was still not resolved.The procedure was not able to be completed as another balloon device was not available for use.There were no patient complications reported as a result of this event.

Event Description

Note: this report pertains to two cre pro gi wireguided dilation balloons and two alliance inflation syringes used during the same patient and procedure.It was reported to boston scientific corporation that two cre pro gi wireguided dilation balloons and two alliance inflation syringes were used during a procedure performed on an unknown date.According to the complainant, during the procedure, it was noticed that the balloon seemed to be inflated on the fluoroscopy; however, the needle of the syringe did not move at all.Reportedly, a second cre pro gi wireguided dilation balloon was used but the issue was not resolved.Then, a second alliance inflation syringe was used but the issue was still not resolved.The procedure was not able to be completed as another balloon device was not available for use.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b3: date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block e1: initial reporter facility name: (b)(6) hospital.Block h6: problem code 1184 captures the reportable issue of gauge reading inaccurate.Device code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: investigation result: a visual examination of the returned complaint device does not have any visual defects.It was noticed that the gauge needle indicated 0 atm when received.Functional evaluation was performed, and the device was pressurized using 35 ml of sterile water; no issues were noted.Based on the analysis performed and the information provided, the most probable root cause for the complaint event cannot be detected since the reported device complaint or problem cannot be confirmed.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.

• 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: 10750115
• MDR Text Key: 225262847
• Report Number: 3005099803-2020-04849
• 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
• Report Date: 11/25/2020

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 Model Number: M00550601
• Device Catalogue Number: 5060-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1