MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ALLIANCE¿ II; SYRINGE, BALLOON INFLATION

Model Number M00550601

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(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

It was reported to boston scientific corporation that an alliance inflation syringe was used in the esophagus during an esophageal dilatation procedure performed on an unknown date.According to the complainant, during the procedure, when the balloon was inflated the gauge needle did not move.The procedure was completed with another alliance inflation syringe.There have been no patient complications as a result of this event.Attempts to obtain additional patient and procedure information have been unsuccessful.Should additional relevant details become available, a supplemental report will be submitted.

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe was used in the esophagus during an esophageal dilatation procedure performed on an unknown date.According to the complainant, during the procedure, when the balloon was inflated the gauge needle did not move.The procedure was completed with another alliance inflation syringe.There have been no patient complications as a result of this event.Attempts to obtain additional patient and procedure information have been unsuccessful.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Investigation results: visual examination of the returned complaint device did not show visual defects.A functional evaluation was performed and no leaking was observed when the syringe assembly was pressurized to 10 atm with 35 ml of sterile water.The needle was checked and no abnormalities were noted with it.Product analysis could not confirm the reported complaint.Therefore the root cause for this complaint cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no other complaints exist for the specified lot.

• Brand Name: ALLIANCE¿ II
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 7550558
• MDR Text Key: 109447163
• Report Number: 3005099803-2018-01580
• 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: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2019
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0020893222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1