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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 Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/22/2017
Event Type  malfunction  
Manufacturer Narrative
Complainant name: (b)(6) medical ctr.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
 
Event Description
It was reported that shaft break occurred.The target lesion was located in the left femoral vein.A 16-4/5.8/75 xxl¿ esophageal balloon catheter was advanced for dilatation.However, the balloon broke off inside the sheath.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.
 
Manufacturer Narrative
Device evaluated by mfr.: the complaint device was received for analysis.The balloon bond, balloon and tip of the device were completely detached from the shaft of the device.The shaft was not returned for analysis.The balloon and balloon bond was completely detached from the shaft at the site of the balloon bond.Blood was visible on the outside of the balloon.Due to the condition of the returned device it was not possible to inflate the balloon.A visual and microscopic examination of the balloon and balloon bond could not find any damage or tear¿s within the balloon material.No issues were noted with the balloon or balloon bond which could have contributed to the complaint incident.A visual and microscopic examination identified no damage or issues with the tip or markerbands of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as the device is an esophageal balloon but it was used in the iliac vein and the dfu states: ''the xxl balloon dilatation catheter is intended for use in adult and adolescent populations to dilate strictures of the esophagus.'' (b)(4).
 
Event Description
It was reported that shaft break occurred.The target lesion was located in the left femoral vein.A 16-4/5.8/75 xxl¿ esophageal balloon catheter was advanced for dilatation.However, the balloon broke off inside the sheath.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 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 Key6618982
MDR Text Key76888092
Report Number2134265-2017-05763
Device Sequence Number1
Product Code KNQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K952656
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2020
Device Model NumberM001145520
Device Catalogue Number14-552
Device Lot Number0020342769
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age94 YR
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