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

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 upn and lot number.Therefore, the manufacture and expiration dates are unknown.(b)(6).(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

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.

• 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: 10750097
• MDR Text Key: 222401684
• Report Number: 3005099803-2020-04981
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K922573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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