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

Model Number M001145520

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

Same case as mdr id 2134265-2018-00300 and 2134265-2018-00301.It was reported that balloon tear occurred.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified iliac venous system with two previously implanted bilateral stents having ostial tightness.After a.035 non-bsc guide wire crossed the lesion, a 16-4/5.8/75 xxl¿ esophageal balloon catheter was advanced for dilatation.However, while being inserted over the guide wire, the balloon was torn.The device was completely removed from the patient and two 16-4/5.8/75 xxl¿ esophageal balloon catheters were advanced and inflated simultaneously.However, during inflation at 2 atmospheres, both balloons ruptured.The devices were completely removed from the patient and the procedure was completed with another 16-4/5.8/75 xxl¿ esophageal balloon catheter.No patient complications were reported and the patient's status was stable.

• 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: 7227967
• MDR Text Key: 98846234
• Report Number: 2134265-2018-00299
• 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: Physician
• Type of Report: Initial
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2020
• Device Model Number: M001145520
• Device Catalogue Number: 14-552
• Device Lot Number: 0021390474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2017
• 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