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

Model Number	M00545101
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that an autocap rx was used for the endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2025.When they attempted to put the locking device on the ercp scope, it was observed that the packaging was opened and sterility was compromised.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event of packaging seal compromised.
Event or Problem Description
It was reported to boston scientific that an autocap rx was used for the endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2025.When they attempted to put the locking device on the ercp scope, it was observed that the packaging was opened and sterility was compromised.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event of packaging seal compromised.Block h11: investigation results the product was not returned for analysis.However, upon media inspection of the photo provided by the account, the device packaging is found to be open with no seal marks present.The reported event was confirmed.As per visual inspection performed to the photo provided, there is no seal or evidence of heat marks on the pouch.Based on all gathered information, the event is assigned a probable cause of manufacturing deficiency, which indicates that there were problems traced to the manufacturing process resulting in an unsealed pouch.An investigation to address this problem is in progress.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21942183
• Report Number: 3005099803-2025-01964
• Device Sequence Number: 8691539
• Product Code: ODC
• UDI-Device Identifier: 08714729994695
• UDI-Public: (01)08714729994695(17)280127(10)20755072
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/23/2025

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
• Device Lot Number: 0020755072
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 06/23/2025
• Date Device Manufactured: 01/27/2025
• 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