MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HURRICANE RX; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00545960
Medical Device Problem Codes	Burst Container or Vessel (1074); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, the balloon exploded.The device was removed, and it was observed that a residue would have potentially remained in the patient's body.Boston scientific has been unable to obtain clarifying information regarding the alleged residue to date, despite good faith efforts.The procedure was completed with another hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, the balloon exploded.The device was removed, and it was observed that a residue would have potentially remained in the patient's body.Boston scientific has been unable to obtain clarifying information regarding the alleged residue to date, despite good faith efforts.The procedure was completed with another hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to (b)(6) 2022 as no event date was reported.Block h6: device code a0402 captures the reportable event of balloon burst.Block h10: investigation result: a visual examination of the returned complaint device found that the catheter of device had no damages.Microscopic analysis was performed, and it was noticed that the balloon was torn circumferentially and ruptured.The lumen of the guidewire was also found to be stretched.No other problems with the device were noted.The reported event of balloon burst was confirmed.The torn circumferential problem is likely due to factors encountered during the procedure, such as excess pressure, the interaction with other devices or anatomical affairs.However, it is possible that interaction with any surface during the procedure could have created friction, resulting in the found failure of torn circumferential.Additionally, the lumen guidewire was stretched and the balloon ruptured.These failure are likely due to the manner as the device was handled and manipulated may have caused the reported and encountered failure.Excessive manipulation of the device without enough care could have induced the problem found.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

• Brand Name: HURRICANE RX
• Common Device Name: 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14175020
• Report Number: 3005099803-2022-02162
• Device Sequence Number: 15014171
• Product Code: FGE
• UDI-Device Identifier: 08714729283874
• UDI-Public: 08714729283874
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K001338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2023
• Device Model Number: M00545960
• Device Catalogue Number: 4596
• Device Lot Number: 0027459532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown