NAJA

Additional Manufacturer Narrative

BLOCK H6: IMDRF CODE A140101 CAPTURES THE REPORTABLE EVENT OF FAILURE TO DEFLATE IMDRF CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED (WIRE CUTTER). BLOCK H11: INVESTIGATION RESULTS SUMMARY. THE NAJA GASTROINTESTINAL BALLOON CATHETER WAS NOT RETURNED FOR ANALYSIS AS IT WAS DISPOSED. THEREFORE, THE TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE REPORTED EVENT OF BALLOON FAILURE TO DEFLATE COULD NOT BE CONFIRMED DUE TO THE LACK OF EVIDENCE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED COMPLAINT. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF BALLOON FAILURE TO DEFLATE AND ADDITIONAL DEVICE REQUIRED WERE DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF UNABLE TO EXCLUDE DEVICE PROBLEM.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A NAJA GASTROINTESTINAL BALLOON CATHETER WAS USED DURING AN ENDOSCOPIC ULTRASOUND GUIDED GASTROJEJUNOSTOMY (EUS-GJ) ON (B)(6) 2026. DURING REMOVAL OF NAJA BALLOON CATHETER, THE DISTAL BALLOON WOULD NOT DEFLATE. THE CATHETER WAS CUT WITH A WIRE CUTTER, AND THE PHYSICIAN LET THE AIR GRADUALLY COME OUT. ADDITIONALLY, THERE WAS A KINK IN THE CATHETER NEAR THE HUB. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

Additional Manufacturer Narrative

BLOCK H6: IMDRF CODE A140101 CAPTURES THE REPORTABLE EVENT OF FAILURE TO DEFLATE. IMDRF CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED (WIRE CUTTER). CORRECTION: CORRECTION TO FIELD H1: TYPE OF REPORTABLE EVENT.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A NAJA GASTROINTESTINAL BALLOON CATHETER WAS USED DURING AN ENDOSCOPIC ULTRASOUND GUIDED GASTROJEJUNOSTOMY (EUS-GJ) ON (B)(6) 2026. DURING REMOVAL OF NAJA BALLOON CATHETER, THE DISTAL BALLOON WOULD NOT DEFLATE. THE CATHETER WAS CUT WITH A WIRE CUTTER, AND THE PHYSICIAN LET THE AIR GRADUALLY COME OUT. ADDITIONALLY, THERE WAS A KINK IN THE CATHETER NEAR THE HUB. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A NAJA GASTROINTESTINAL BALLOON CATHETER WAS USED DURING AN ENDOSCOPIC ULTRASOUND GUIDED GASTROJEJUNOSTOMY (EUS-GJ) ON (B)(6) 2026. DURING REMOVAL OF NAJA BALLOON CATHETER, THE DISTAL BALLOON WOULD NOT DEFLATE. THE CATHETER WAS CUT WITH A WIRE CUTTER, AND THE PHYSICIAN LET THE AIR GRADUALLY COME OUT. ADDITIONALLY, THERE WAS A KINK IN THE CATHETER NEAR THE HUB. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

Additional Manufacturer Narrative

BLOCK H6: IMDRF CODE A140101 CAPTURES THE REPORTABLE EVENT OF FAILURE TO DEFLATE. IMDRF CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED.