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

Model Number M001145520

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported the sterility was compromised.A 16-4/5.8/75 xxl¿ esophageal balloon catheter was selected for use to dilate the lesion.However, during unpacking, there was a visible hole in the package.The procedure was completed with a different device.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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5976104
• MDR Text Key: 55565575
• Report Number: 2134265-2016-08460
• 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: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2019
• Device Model Number: M001145520
• Device Catalogue Number: 14-552
• Device Lot Number: 19478002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2016
• 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