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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - GALWAY XXL¿ ESOPHAGEAL DILATOR, ESOPHAGEAL Back to Search Results
Model Number M001145520
Device Problems Balloon; Torn Material
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.

 
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Brand NameXXL¿ ESOPHAGEAL
Type of DeviceDILATOR, 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 Key7227967
Report Number2134265-2018-00299
Device Sequence Number1
Product CodeKNQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/08/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/30/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM001145520
Device Catalogue Number14-552
Device LOT Number0021390474
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/15/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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