MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTIFLO HEMOSTASIS CATHETER; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M00511751
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an optiflo hemostasis catheter was used in the colon during an enteric polyp excision procedure performed on (b)(6) 2020.According to the complainant, during withdrawal, the needle was retracted abnormally and part of the needle tip was exposed, which pricked the finger of the medical staff.The patient was found positive for hepatitis b and the medical staff immediately injected immunoglobulin for emergency treatment.The procedure was completed with another optiflo hemostasis catheter.There were no patient complications reported as a result of this event.The patients condition following the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that an optiflo hemostasis catheter was used in the colon during an enteric polyp excision procedure performed on (b)(6) 2020.According to the complainant, during withdrawal, the needle was retracted abnormally and part of the needle tip was exposed, which pricked the finger of the medical staff.The patient was found positive for hepatitis b and the medical staff immediately injected immunoglobulin for emergency treatment.The procedure was completed with another optiflo hemostasis catheter.There were no patient complications reported as a result of this event.The patients condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: patient code e2010 is being used to capture the reportable issue of the needle tip was exposed which pricked the finger of the medical staff.Block h10: investigation results: the returned optiflo hemostasis catheter was analyzed, a visual evaluation was performed and no damages or additional defects were found.A functional evaluation noted that the needle extended and retracted at the moment to activate the handle.Based on all available information and the condition of the returned device, most likely an inadequate interaction between the user and device could have caused the needle to not fully retract into the sheath leading into the user pricking their finger.The investigation concluded the most probable cause is unintended use error.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 directions for use (dfu) / product label.

• Brand Name: OPTIFLO HEMOSTASIS CATHETER
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10951734
• Report Number: 3005099803-2020-05839
• Device Sequence Number: 16865147
• Product Code: KOG
• UDI-Device Identifier: 08714729145264
• UDI-Public: 08714729145264
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K953338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2022
• Device Model Number: M00511751
• Device Catalogue Number: 1175
• Device Lot Number: 0005925591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Weight: 65