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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 M001145540
Device Problems Shaft; Material Perforation; Device Damaged by Another Device
Event Date 06/27/2016
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

Same case as mdr id 2134265-2016-07209. It was reported that shaft perforation occurred. The target lesion was located in the iliac vein. A 16-6/5. 8/75 xxl¿ esophageal balloon catheter was loaded over an amplatz guide wire. However, upon connection to the inflation device, blood was observed and perforation was noted on the balloon catheter. The device was removed and the procedure was completed with another of the same device. No patient complications were reported and the patient's status was fine.

 
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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
linda leimer
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key5822798
Report Number2134265-2016-07025
Device Sequence Number1
Product CodeKNQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/27/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/26/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/01/2019
Device MODEL NumberM001145540
Device Catalogue Number14-554
Device LOT Number19322235
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 Received06/27/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/09/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/26/2016 Patient Sequence Number: 1
Treatment
GUIDEWIRE: AMPLATZ
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