MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY XXL¿ ESOPHAGEAL; DILATOR, ESOPHAGEAL

Model Number M001145570

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that product sterility was compromised.An 18-4/5.8/75 xxl¿ esophageal balloon catheter was selected for use.However, during unpacking, the device looked like it was not sterile anymore.The sterile bag was damaged.The whole package was noticed to be ruptured and the box was damaged.The device was never used in the patient.No patient complications were reported.

• Brand Name: XXL¿ ESOPHAGEAL
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6975139
• MDR Text Key: 90781049
• Report Number: 2134265-2017-10369
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2020
• Device Model Number: M001145570
• Device Catalogue Number: 14-557
• Device Lot Number: 0021051976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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