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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pancreatitis (4481); Restenosis (4576); Insufficient Information (4580)
Event Date 03/22/2021
Event Type  Injury  
Manufacturer Narrative
Date of event was approximated to be (b)(6) 2021 as no specific event date was reported. The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. (b)(4). The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation on march 22, 2021 that a habib endohpb rf catheter was used to treat an ampullary adenoma during a radiofrequency ablation (rfa) procedure performed some time in 2020. On an unknown date, the patient developed a stricture in the proximal common bile duct. The physician suspects that the stricture was related to the previous use of the habib during the radiofrequency ablation (rfa) procedure or related to the disease progression of the ampullary adenoma. A plastic stent was implanted to treat the stricture. The patient's condition at the conclusion of the procedure is unknown.
 
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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 Key11673614
MDR Text Key246431293
Report Number3005099803-2021-01759
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberM00500070
Device Catalogue Number2244-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/15/2021 Patient Sequence Number: 1
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