MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RX LOCKING DEVICE; ENDOSCOPE CHANNEL ACCESSORY

Model Number	M00545211
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(6).The complainant was unable to report the device lot number; therefore, the manufacture date and the expiration date are unknown.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an rx locking device biopsy cap was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on unknown date.During the procedure, the rx locking device fails to lock on the wire.Additionally, tension that the rx locking device puts on the wire leads to leaking of the biopsy cap.Reportedly, bile and stomach fluid leaks from the endoscope onto the nurses, endoscopists, and the floor.Reportedly, personnel are wearing standard personal protective equipment.Due to these problems, procedure is prolonged and in some cases procedure is not completed.There were no patient complications reported as a result of this event.

• Brand Name: RX LOCKING DEVICE
• Common Device Name: ENDOSCOPE CHANNEL ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11327224
• Report Number: 3005099803-2021-00523
• Device Sequence Number: 2581339
• Product Code: ODC
• UDI-Device Identifier: 08714729440604
• UDI-Public: 08714729440604
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010610
• 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
• Report Date (Section B): 02/15/2021

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 Model Number: M00545211
• Device Catalogue Number: 4521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1