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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an alliance inflation syringe was used in the ampulla during an endoscopic papillary balloon dilation (epbd) procedure performed on (b)(6) 2022.During procedure, it was noticed that the gauge did not go up.The procedure was completed with another alliance inflation syringe.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

(b)(4).

• 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: 15629409
• MDR Text Key: 307160306
• Report Number: 3005099803-2022-06062
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729129332
• UDI-Public: 08714729129332
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K922573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2022

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: 03/13/2024
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0029037467
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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