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

Model Number	23375
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon pinhole occurred.The target lesion was located in the anterior tibial artery.After flushing, a 18-4/5.8/120 xxl esophageal balloon catheter was advanced for dilation.However, upon inflation, it was noticed that there was leakage of contrast media from the balloon.The device was removed and upon inflation outside the patient, it was noted that the was a tiny hole on the side of the balloon.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.
Event or Problem Description
It was reported that balloon pinhole occurred.The target lesion was located in the anterior tibial artery.After flushing, a 18-4/5.8/120 xxl esophageal balloon catheter was advanced for dilation.However, upon inflation, it was noticed that there was leakage of contrast media from the balloon.The device was removed and upon inflation outside the patient, it was noted that the was a tiny hole on the side of the balloon.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure of 8 atmospheres without issue.A vacuum was then applied.The inflation device was verified at 8 atmospheres, before and after use.This inflation to rate of burst pressure was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found that the shaft was severely kinked at the distal edge of the strain relief.No other issues were identified during the product analysis.

• Brand Name: XXL ESOPHAGEAL
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9654520
• Report Number: 2134265-2020-00717
• Device Sequence Number: 2361887
• Product Code: KNQ
• UDI-Device Identifier: 08714729163176
• UDI-Public: 08714729163176
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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 Expiration Date: 09/16/2021
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0022662926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Received by Manufacturer: 01/12/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 70