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

Model Number	M00545271
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).According to the complainant, the suspect device is contaminated 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 a biopsy cap was used in biliary ducts during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, a snare was passed through the biopsy cap and one of the pieces inside of the cap went into the working channel and was very difficult to remove the detached component.Reportedly, a water soluble lubricant was not placed on the biopsy cap prior to use.The procedure was completed with another duodenoscope.There were no patient complications reported as a result of this event.

• Brand Name: RX LOCKING DEVICE AND BIOPSY CAP
• Common Device Name: ENDOSCOPE CHANNEL ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11995783
• Report Number: 3005099803-2021-02777
• Device Sequence Number: 10993625
• Product Code: ODC
• UDI-Device Identifier: 08714729296621
• UDI-Public: 08714729296621
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 06/14/2021

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: M00545271
• Device Catalogue Number: 4527
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1