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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HABIB ENDOHPB UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC CORPORATION HABIB ENDOHPB UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00500070
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/31/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device has not been received for analysis. Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation on (b)(6) 2022 that a habib endohpb rf catheter was used to treat a hilar bile duct stenosis during a radiofrequency ablation procedure performed on (b)(6) 2022. During the procedure, the device was able to cauterize the right hepatic duct; however, there was difficulty in removing the catheter. Eventually, the catheter was pulled out with force. The physician then cauterized the left hepatic duct but the catheter was again difficult to remove. The catheter was removed with force, and the electrode detached and fell in the bile duct. The electrode was attempted to be removed with forceps but it fell on the liver side of the stenosis. The detached electrode remained inside the patient and the procedure was completed. There were no patient complications as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.
 
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Brand NameHABIB ENDOHPB
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
STATICE MANUFACTURING
9 rue thomas edison
besancon 25000
FR 25000
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key14172638
MDR Text Key289896582
Report Number3005099803-2022-02082
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K180165
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00500070
Device Catalogue Number2244-01
Device Lot Number0564990010
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/21/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/21/2022 Patient Sequence Number: 1
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