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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HURRICANE RX; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION HURRICANE RX; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number M00545920
Device Problems Break (1069); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2023
Event Type  Injury  
Event Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used in the biliary during an eus-guided antegrade stenting procedure performed on (b)(6) 2023.During the procedure, the dilation catheter was advanced through the biliary stenosis over the wire and was inflated without a problem.Upon its deflation, confirmed by the disappearance of the contrast medium under fluoroscopy, the attempt to retract the catheter was unsuccessful.The balloon remained trapped inside the stenosis.With further attempts to extract it, the core of the catheter broke.After breaking, it was finally retrieved with a snare through endoscopic retrograde cholangiopancreatography (ercp).The procedure was completed using another technique (ercp), which allowed the removal of the device residue endoscopically, avoiding surgery.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter break.
 
Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter break.Block h10: investigation results: the returned hurricane rx dilatation balloon was analyzed, and a visual examination found that the catheter was extremely stretched, even the catheter was broken.The catheter was kinked about 3 mm from the distal end.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of catheter break was confirmed.The results of the analysis performed on the returned device showed that the catheter was severely stretched and broken, this fact suggests that the device was pulled to the point where it breaks.The tip of the catheter was also found to be kinked, possibly a consequence of the same manipulation.Perhaps the technique used, or the anatomical conditions of the patient, may have contributed to these events.Therefore, the most probable root cause is an adverse event related to procedure.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/product label.
 
Event Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used in the biliary during an eus-guided antegrade stenting procedure performed on (b)(6) 2023.During the procedure, the dilation catheter was advanced through the biliary stenosis over the wire and was inflated without a problem.Upon its deflation, confirmed by the disappearance of the contrast medium under fluoroscopy, the attempt to retract the catheter was unsuccessful.The balloon remained trapped inside the stenosis.With further attempts to extract it, the core of the catheter broke.After breaking, it was finally retrieved with a snare through endoscopic retrograde cholangiopancreatography (ercp).The procedure was completed using another technique (ercp), which allowed the removal of the device residue endoscopically, avoiding surgery.There were no patient complications reported as a result of this event.
 
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Brand Name
HURRICANE RX
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
cork business technology park
model farm road
cork T12 Y K88
EI   T12 YK88
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key18051637
MDR Text Key327127226
Report Number3005099803-2023-05919
Device Sequence Number1
Product Code FGE
UDI-Device Identifier08714729283836
UDI-Public08714729283836
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K001338
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00545920
Device Catalogue Number4592
Device Lot Number0031425192
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/12/2023
Initial Date FDA Received11/01/2023
Supplement Dates Manufacturer Received12/14/2023
Supplement Dates FDA Received01/05/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2023
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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