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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 M001145550
Device Problems Balloon; Detachment Of Device Component; Difficult to Remove ; Material Rupture; Torn Material; Catheter
Event Date 10/04/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that a balloon rupture, difficulty removing, a balloon tear, and balloon detachment occurred. The balloon fragment was unable to be retrieved. The target lesion was located in the common iliac vein. A 18-2/5. 8/75 xxl¿ esophageal balloon catheter was advanced for post-dilation. The balloon ruptured and force was used in an attempt to remove the balloon through the sheath, when a circumferential tear as noted and the balloon detached from the shaft and was floating over the guidewire inside the patient. Snaring was attempted, however, unsuccessful. A wallstent was deployed to trap the balloon components against the vessel wall. The procedure was complete and the patient status was fine.

 
Manufacturer Narrative

Device evaluated by mfr. : the device was returned for analysis. The distal section of the device consisting of shaft, balloon material, tip and marerkerbands was not returned for analysis. A visual examination identified a completed circumferential tear in the balloon approximately 14mm distal to the proximal balloon bond. The break in the shaft was identified 15mm distal to the balloon bond. No issues were noted with the shaft or balloon material that could have contributed to the complaint incident. One kink was noted 1mm distal to the strain relief. The damage observed is consistent with excessive force being applied to the delivery system which may have occurred when the physician attempted to remove the device after the balloon tore circumferentially. The distal detached section of the device was not returned for analysis. 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 investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user. 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 further reported that the physician was not using an inflation device, instead had the balloon attached to a large syringe and was inflating by hand and on initial inflation, the balloon ruptured.

 
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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 Key6970874
Report Number2134265-2017-10381
Device Sequence Number1
Product CodeKNQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM001145550
Device Catalogue Number14-555
Device LOT Number0020774780
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/19/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/26/2017
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: 10/24/2017 Patient Sequence Number: 1
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