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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the non-tortuous and mildly calcified common iliac artery.A 16-6/5.8/75 xxl esophageal balloon dilator was advanced for post dilatation of a previously placed stent.However, during initial inflation at 4 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed with another 16-6/5.8/75 xxl esophageal balloon dilator.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: an xxl/16-6/5.8/75 was received for analysis.A visual examination identified that the balloon was not folded, and inflation media was present inside it 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 5 atmospheres for 30 seconds using digital timer without issue.A vacuum was then applied.The inflation device was verified at 5 atmospheres, before and after use with calibrated pressure gauge.This inflation to rate of burst pressure of 5 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.As per xxl specification, the rated burst pressure for this device is 5 atmospheres.No issues were noted with the tip section of the device.A visual examination found no issue with the markerbands.A visual and tactile examination found that the shaft was kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the non-tortuous and mildly calcified common iliac artery.A 16-6/5.8/75 xxl esophageal balloon dilator was advanced for post dilatation of a previously placed stent.However, during initial inflation at 4 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed with another 16-6/5.8/75 xxl esophageal balloon dilator.There were no patient complications nor injuries reported.It was further reported that the balloon ruptured at 2 atmospheres for less than 15 seconds.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the non-tortuous and mildly calcified common iliac artery.A 16-6/5.8/75 xxl esophageal balloon dilator was advanced for post dilatation of a previously placed stent.However, during initial inflation at 4 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed with another 16-6/5.8/75 xxl esophageal balloon dilator.There were no patient complications nor injuries reported.It was further reported that the balloon ruptured at 2 atmospheres for less than 15 seconds.

• Brand Name: XXL ESOPHAGEAL
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15611297
• Report Number: 2124215-2022-41548
• Device Sequence Number: 15248739
• Product Code: KNQ
• UDI-Device Identifier: 08714729163114
• UDI-Public: 08714729163114
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2022

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: 02/16/2025
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0028886558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 10/18/2022; 11/15/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 10/21/2022; 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 99 KG