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	04/11/2023
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.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Mdrf device code a0501 captures the reportable event of the white sponge within the clear biopsy cap had been dislodged.
Event or Problem Description
It was reported to boston scientific corporation that a rx locking / biopsy cap was to be used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) on unknown date.During the procedure, while passing a hydratome 44, the white sponge within the transparent biopsy cap was dislodged in the scope.The sponge was successfully removed from the scope with forceps.A water soluble lubricant was not applied to the rx locking device biopsy cap prior to use.Another rx locking / biopsy cap was used to complete the procedure.There was no patient complication as a result of this event.
Additional Manufacturer Narrative
Block b5 and h2 were updated based on additional information received that the correct event/procedure date is (b)(6) 2023.Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: mdrf device code a0501 captures the reportable event of the white sponge within the clear biopsy cap had been dislodged.
Event or Problem Description
It was reported to boston scientific corporation that a rx locking / biopsy cap was to be used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) on (b)(6) 2023.During the procedure, while passing a hydratome 44, the white sponge within the transparent biopsy cap was dislodged in the scope.The sponge was successfully removed from the scope with forceps.A water soluble lubricant was not applied to the rx locking device biopsy cap prior to use.Another rx locking / biopsy cap was used to complete the procedure.There was no patient complication 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16902733
• Report Number: 3005099803-2023-02298
• Device Sequence Number: 5371537
• Product Code: ODC
• UDI-Device Identifier: 08714729296621
• UDI-Public: 08714729296621
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown