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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 Break (1069); Material Rupture (1546); Device-Device Incompatibility (2919)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/13/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that balloon rupture and shaft detachment occurred.The target lesion was located in the right external iliac vein.A 16-6 x 5.8 x 75 xxl esophageal balloon catheter was advanced for dilatation, however, it was noted that the balloon ruptured due to contact with the stent upon retracting the balloon out of the patient 's body.The balloon and delivery system become separated.The physician retracted the sheath revealing the balloon in the subcutaneous tissue and they used a pair of hemostats to retract the rest of the device way over the wire.They re-inserted the dilator and put the sheath back in the groin.The device was completely removed from the patient and the procedure was completed with a different device.No patient complications were reported and the patients status was fine.
 
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that balloon rupture and shaft detachment occurred.The target lesion was located in the right external iliac vein.A 16-6 x 5.8 x 75 xxl esophageal balloon catheter was advanced for dilatation, however, it was noted that the balloon ruptured due to contact with the stent upon retracting the balloon out of the patient 's body.The balloon and delivery system become separated.The physician retracted the sheath revealing the balloon in the subcutaneous tissue and they used a pair of hemostats to retract the rest of the device way over the wire.They re-inserted the dilator and put the sheath back in the groin.The device was completely removed from the patient and the procedure was completed with a different device.No patient complications were reported and the patients status was fine.Device evaluated by manufacturer: a visual examination identified a complete circumferential tear of the balloon material approximately 10mm distal from the proximal sleeve of the balloon.The distal section of balloon material had completely detached from the balloon to distal tip bond.The distal section of balloon material measuring approximately 90mm was completely detached from the device.A visual and microscopic examination was performed on the balloon material and no issues were noted that could have contributed to the complaint incident.A visual and tactile examination identified no issue or damage to the shaft of the device.A visual and microscopic examination of the tips and markerbands identified no damage or any issues that could have contributed to the complaint incident.No other issues were identified during the product analysis.
 
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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
MDR Report Key7944497
MDR Text Key123733643
Report Number2134265-2018-61654
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier08714729163114
UDI-Public08714729163114
Combination Product (y/n)N
PMA/PMN Number
K952656
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 10/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/17/2021
Device Model Number23375
Device Catalogue Number23375
Device Lot Number0022532419
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2018
Date Manufacturer Received10/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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