AUTOCAP RX
Received Feb 2, 2026 · Event occurred Jan 7, 2026
Report 3005099803-2026-00411 · MDR key 24240544
Device
Generic name
Endoscope Channel Accessory
Manufacturer
Boston Scientific CorporationModel number
M00545101Catalog number
4510
Lot number
0021306085
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AUTOCAP RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR THE TREATMENT OF STONES ON (B)(6) 2026. DURING THE PROCEDURE, THE FOAM PIECE FROM THE AUTOCAP RX DETACHED FROM THE CAP. THE PROCEDURE WAS COMPLETED WITH A SECOND AUTOCAP RX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
BLOCK E1: (B)(6). BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF THE SPONGE DETACHMENT.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AUTOCAP RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR THE TREATMENT OF STONES ON (B)(6) 2026. DURING THE PROCEDURE, THE FOAM PIECE FROM THE AUTOCAP RX DETACHED FROM THE CAP. THE PROCEDURE WAS COMPLETED WITH A SECOND AUTOCAP RX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION WAS RECEIVED ON FEBRUARY 3, 2026: IT WAS REPORTED THAT THE ANATOMY LOCATION OF THE PROCEDURE IS COMMON BILE DUCT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: BLOCK B5 (DESCRIBE EVENT OR PROBLEM). BLOCK E1: (B)(6). BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF THE SPONGE DETACHMENT.