MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XXL VASCULAR; 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	12/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the infrarenal iliac vessel.A 14-4/5.8/120 xxl balloon catheter was advanced for dilatation.However, during the first inflation at 4 atmospheres, the balloon ruptured.The device was completely removed and the procedure was completed with another of the same device.No patient complications were reported and the patient was all right.
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Device evaluated by mfr.: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A microscopic examination identified a balloon longitudinal tear beginning 3mm distal of the distal markerboard and extending 10mm proximally.An examination of the balloon material and markerband identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 8 atmospheres as per xxl.A visual and tactile examination identified no issues with the tip of the device that could have contributed to the complaint incident.A visual and tactile examination identified no issues with the shaft.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the infrarenal iliac vessel.A 14-4/5.8/120 xxl balloon catheter was advanced for dilatation.However, during the first inflation at 4 atmospheres, the balloon ruptured.The device was completely removed and the procedure was completed with another of the same device.No patient complications were reported and the patient was all right.

• Brand Name: XXL VASCULAR
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9556007
• Report Number: 2134265-2019-16469
• Device Sequence Number: 381519
• Product Code: LIT
• UDI-Device Identifier: 08714729190479
• UDI-Public: 08714729190479
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K150303
• 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): 03/16/2020

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: 01/06/2022
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0023146968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 12/21/2019
• Supplement Date Received by Manufacturer: 02/23/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1