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

Model Number	M00545101
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an autocap rx was used in bile duct during an endoscopic retrograde cholangiopancreatography (ercp) on (b)(6) 2024, for the treatment of biliary obstruction.During the procedure, the yellow sponge came out on top of the autocap locking device.The sponge was not pushed inside the scope.The procedure was completed using another of the same device.There was no patient complication as a result of this event.
Additional Manufacturer Narrative
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: imdrf device code a0501 captures the reportable event of the sponge detachment.
Additional Manufacturer Narrative
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: imdrf device code a0501 captures the reportable event of the sponge detachment.Block h11: additional information received on august 26, 2024, confirmed that this is no longer considered a reportable event.The mdr reported event 3005099803-2024-03739 is a duplicate complaint.There were only two events.The first complaint was reported on mdr 3005099803-2024-03200 and the second mdr reported complaint was on 3005099803-2024-03710.
Event or Problem Description
It was reported to boston scientific corporation that an autocap rx was used in bile duct during an endoscopic retrograde cholangiopancreatography (ercp) on (b)(6) 2024, for the treatment of biliary obstruction.During the procedure, the yellow sponge came out on top of the autocap locking device.The sponge was not pushed inside the scope.The procedure was completed using another of the same device.There was no patient complication as a result of this event.See block h11 for additional information that was received on august 26, 2024.

• Brand Name: AUTOCAP RX
• Common Device Name: ENDOSCOPE CHANNEL ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): NOLATO CONTOUR INC; 660 vandeberg street; baldwin WI 54002
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19937996
• Report Number: 3005099803-2024-03739
• Device Sequence Number: 15311570
• Product Code: ODC
• UDI-Device Identifier: 08714729994695
• UDI-Public: 08714729994695
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K210353
• 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): 09/18/2024

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: M00545101
• Device Catalogue Number: 4510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 09/18/2024
• 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