MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE; DILATOR, ESOPHAGEAL

Catalog Number M00558380

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2016

Event Type  malfunction  

Event Description

The first balloon dilator (lot# 18884819) that was used did not go all the way through the biopsy channel.It was tried twice with no success.The balloon catheter would get jammed/stuck in the scope.The catheter was removed and a new catheter was used to dilate esophagus.The second balloon catheter (lot# 18846982) would not deflate 100% for it to be removed safely through the scope.The scope had to be removed from the patient and the balloon portion of the catheter was cut/separated from the rest of the catheter.The remaining part of the balloon catheter was safely removed from scope.The procedure was able to be completed with a new catheter with no complications to the patient.Manufacturer response for esophageal balloon catheter, cre esophageal fixed wire 18-20 (per site reporter): sent 2 replacements.Obtained information for their report.

• Brand Name: CRE
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough, MA 01752
• MDR Report Key: 5624471
• MDR Text Key: 44212125
• Report Number: 5624471
• Device Sequence Number: 1
• Product Code: KCF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: M00558380
• Device Lot Number: 18884819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 71