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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XXL VASCULAR; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC CORPORATION XXL VASCULAR; DILATOR, ESOPHAGEAL Back to Search Results
Model Number 23375
Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Patient Problem No Code Available (3191)
Event Date 10/21/2019
Event Type  Injury  
Event Description
It was reported that balloon detachment and balloon rupture occurred.The target lesion was located in anon calcified, non tortuous, very straight segment a fistula in an upper extremity.After a stent was deployed, a 14-6/5.8/75 xxl vascular balloon catheter was advanced for post dilatation.However, during the first inflation at 6 atmospheres for less than 5 seconds, the balloon ruptured.The physician went to remove the device but it was caught on the stent and the balloon material ripped away from the delivery system.The physician used a snare to retrieve the detached portion of the balloon and the procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
 
Event Description
It was reported that balloon detachment and balloon rupture occurred.The target lesion was located in anon calcified, non tortuous, very straight segment a fistula in an upper extremity.After a stent was deployed, a 14-6/5.8/75 xxl vascular balloon catheter was advanced for post dilatation.However, during the first inflation at 6 atmospheres for less than 5 seconds, the balloon ruptured.The physician went to remove the device but it was caught on the stent and the balloon material ripped away from the delivery system.The physician used a snare to retrieve the detached portion of the balloon and the procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
 
Manufacturer Narrative
Lot number: lot number corrected from 0024051484 to 0024047272.Device manufacture date corrected from 07/03/2019 to 07/02/2019.A visual examination identified a complete balloon circumferential tear located approximately 40mm distal of the proximal balloon bond.The distal section of balloon material was completely detached from the device at distal balloon bond.This type of damage is consistent with excessive tensile force being applied to the device.The rate of burst pressure of this device is 8 atmospheres.A visual and tactile examination identified a complete break of the shaft of the device located approximately 30mm distal of the proximal balloon sleeve.The distal section of the shaft together with the distal markerband and tip of the device was not returned for analysis.The shaft was also noted to be severely kinked at the distal edge of the strain relief.This type of damage is consistent with excessive tensile force being applied to the device.A visual examination found that the distal markerband and the tip together with the distal section of detached shaft were not returned for analysis.No other issues were identified during the product analysis.
 
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Brand Name
XXL VASCULAR
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9306368
MDR Text Key166190586
Report Number2134265-2019-13480
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729190486
UDI-Public08714729190486
Combination Product (y/n)N
PMA/PMN Number
K150303
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/02/2022
Device Model Number23375
Device Catalogue Number23375
Device Lot Number0024047272
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2019
Date Manufacturer Received11/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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