inforMED — FDA medical device performance lookup

Device

Generic name

Dilator, Esophageal

Manufacturer

Boston Scientific Corporation

Model number

M00554510

Catalog number

5451

Lot number

C316128

Product problems

Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem

Patient

79 YR · Male

Perforation of Esophagus
Perforation of Esophagus

Narrative

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE ESOPHAGUS WAS PERFORATED. THE ENDOSCOPIST BELIEVED THAT THE PERFORATION WAS CAUSED BY THE RIGID TIP OF THE TUBE RATHER THAN BY BALLOON INFLATION. THIS WAS A SMALL AND LOCALIZED PERFORATION. NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. THE PATIENT WAS 72 YEARS OLD MALE. THE PERFORATION WAS THEN TREATED USING FEW ENDO CLIPS. THE PATIENT UNDERGOES NOTHING BY MOUTH (NBM) AND ON TOTAL PARENTERAL NUTRITION (TPN) DUE TO THIS EVENT. THE PATIENT HAD AN UNEVENTFUL RECOVERY AND WAS DISCHARGED HOME AFTER A WEEK ONCE THE BARIUM DID NOT DEMONSTRATE ANY LEAK.

Additional Manufacturer Narrative

BLOCK H6: IMDRF PATIENT CODE E1022 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF PERFORATION OF THE ESOPHAGUS. IMDRF IMPACT CODE F08 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF PROLONGED HOSPITALIZATION. IMDRF IMPACT CODE F2303 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF MEDICATION REQUIRED. BLOCK H11: ADDITIONAL INFORMATION: BLOCK A2 (AGE AT TIME OF EVENT), BLOCK B5 (DESCRIBE EVENT OR PROBLEM), BLOCK H6 (IMPACT CODES) HAVE BEEN UPDATED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE ESOPHAGUS WAS PERFORATED. THE ENDOSCOPIST BELIEVED THAT THE PERFORATION WAS CAUSED BY THE RIGID TIP OF THE TUBE RATHER THAN BY BALLOON INFLATION. THIS WAS A SMALL AND LOCALIZED PERFORATION. NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

Additional Manufacturer Narrative

BLOCK H6: IMDRF PATIENT CODE E1022 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF PERFORATION OF THE ESOPHAGUS.