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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XXL ESOPHAGEAL; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC CORPORATION XXL ESOPHAGEAL; DILATOR, ESOPHAGEAL Back to Search Results
Model Number 23375
Device Problems Deflation Problem (1149); Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2022
Event Type  Injury  
Event Description
It was reported that balloon deflation issue, balloon detachment and balloon rupture occurred requiring a surgical intervention.The patient underwent iliac vein compression.The target lesion was located in the iliac vein.A 16-4/5.8/75 xxl esophageal balloon catheter was advanced for dilatation.However, during the removal of the device through the sheath, it was noted that the balloon was ruptured and not completely deflated and was detached from the shaft in the popliteal vein.A small cut down was performed to remove the balloon material from the patient's body.The procedure was completed with another of same device.No patient complications were reported.
 
Event Description
It was reported that balloon deflation issue, balloon detachment and balloon rupture occurred requiring a surgical intervention.The patient underwent iliac vein compression.The target lesion was located in the iliac vein.A 16-4/5.8/75 xxl esophageal balloon catheter was advanced for dilatation.However, during the removal of the device through the sheath, it was noted that the balloon was ruptured and not completely deflated and was detached from the shaft in the popliteal vein.A small cut down was performed to remove the balloon material from the patient's body.The procedure was completed with another of same device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: xxl/16-4/5.8/75 was received for analysis.The device was received in three sections due to two shaft breaks.A visual examination identified a complete circumferential tear of the balloon material located at the proximal sleeve of the balloon.The balloon material had been pushed distally and had bunched towards the tip of the device.This type of damage is consistent with excessive tensile force being applied when withdrawing the device through the sheath/guide.The rate of burst pressure of this device is 5 atmospheres as per xxl specification.A visual and tactile examination found the shaft to have been detached at two locations.The proximal shaft break was located approximately 10mm distal of the proximal balloon bond.The second shaft break was located approximately 110mm distal of the proximal shaft break.This type of damage is consistent with excessive tensile force being applied to the device.A visual examination for no damage or issues with the tip of the device.
 
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Brand Name
XXL ESOPHAGEAL
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15129858
MDR Text Key296869828
Report Number2124215-2022-25645
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier08714729163060
UDI-Public08714729163060
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number23375
Device Catalogue Number23375
Device Lot Number0028964816
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2022
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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