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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY XXL¿ VASCULAR; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC - GALWAY XXL¿ VASCULAR; DILATOR, ESOPHAGEAL Back to Search Results
Model Number M001145150
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem Perforation of Vessels (2135)
Event Date 05/29/2015
Event Type  Injury  
Event Description
It was reported that shaft break, catheter removal difficulty and vessel perforation occurred.The target lesion was located in the superior vena cava.A 7fr sheath was placed and a 14-4/5.8/120 xxl¿ vascular balloon catheter was used.After the procedure, an attempt was made to remove the balloon catheter however the shaft of the catheter split and came off, leaving a segment of the balloon and the tip of the shaft on the guide wire inside the patient.A snare was placed over the wire tip and an attempt was done to pull the balloon back through the sheath but this was unsuccessful as the balloon had formed a "ball." both the sheath and the balloon "ball" were removed together.It was then noted that there was a large hole in the vessel which responded to manual compression.The procedure was completed.No further patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Device evaluated by mfr: the device was received in two sections along with a guide wire.A break in the shaft and a complete balloon circumferential tear was evident with the returned device.The circumferential tear in the balloon was located approximately 1cm distal to the proximal markerband.The distal section of the balloon tear was completely bunched up towards the tip.This section of balloon material was unraveled and examined.No other tears or damage was noted with this section of the balloon material.A break was present in the shaft at 1cm distal to the proximal markerband.An examination of the break site found that the shaft was stretched.This type of damage is consistent with excessive tensile force having been applied to the shaft.Approximately 3cm distal from the break site an impression was noted on the shaft, consistent with a clamp or forceps having been applied to the shaft.An examination of the guide wire identified no anomalies.The outer diameter of the guide wire was measured to be within specification for use with this device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factor.(b)(4).
 
Event Description
It was reported that shaft break, catheter removal difficulty and vessel perforation occurred.The target lesion was located in the superior vena cava.A 7fr sheath was placed and a 14-4/5.8/120 xxl¿ vascular balloon catheter was used.After the procedure, an attempt was made to remove the balloon catheter however the shaft of the catheter split and came off, leaving a segment of the balloon and the tip of the shaft on the guide wire inside the patient.A snare was placed over the wire tip and an attempt was done to pull the balloon back through the sheath but this was unsuccessful as the balloon had formed a "ball." both the sheath and the balloon "ball" were removed together.It was then noted that there was a large hole in the vessel which responded to manual compression.The procedure was completed.No further patient complications were reported and the patient's status was stable.
 
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Brand Name
XXL¿ VASCULAR
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4866427
MDR Text Key16542671
Report Number2134265-2015-03911
Device Sequence Number1
Product Code KNQ
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K952656
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,company representati
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/02/2016
Device Model NumberM001145150
Device Catalogue Number14-515
Device Lot Number0015771568
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received08/09/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/03/2013
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 Outcome(s) Required Intervention;
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