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

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.

Manufacturer Narrative

Blocks b5 and h6 (impact codes) have been updated with additional information received on april 26, 2022.Block h6: medical device problem code a0501 captures the reportable event of electrode detached.Block h10: 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.Block h11: block g4 (premarket/510(k)#) has been corrected.

Event Description

It was reported to boston scientific corporation on march 31, 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.Additional information received on april 26, 2022 on (b)(6), 2022, an additional procedure was performed and the detached electrode was successfully removed from the patient.

Event Description

It was reported to boston scientific corporation on march 31, 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.Additional information received on april 26, 2022: on (b)(6) 2022, an additional procedure was performed and the detached electrode was successfully removed from the patient.

Manufacturer Narrative

Block h6: medical device problem code a0501 captures the reportable event of electrode detached.Block h10: a habib endohpb catheter was received for analysis.The security cable was present.Visual inspection found some scratches on the distal tube (due to movement of the crimping tabs).Glue was also present on both sides of the electrode; however, the electrode was ripped off.No further analysis could be performed without the electrode.Product analysis confirmed the reported event of electrode detachment.Based on the available information, there was difficulty in removing the catheter and force was being applied to remove the catheter.It is likely that improper use or inadvertent force could have contributed to the reported event.Therefore, review and analysis of all available information indicated the most probable cause is unintended use error caused or contributed to event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A product labeling review identified that the device was used per the directions for use (dfu) / product label.

• Brand Name: HABIB ENDOHPB
• Type of Device: UNIT, 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 Key: 14172638
• MDR Text Key: 289896582
• Report Number: 3005099803-2022-02082
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729981909
• UDI-Public: 08714729981909
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K180165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00500070
• Device Catalogue Number: 2244-01
• Device Lot Number: 0564990010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male