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

Model Number	23375
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.Vascular access was obtained via the left side.The 60% stenosed, 60mm in length, concentric, de novo target lesion was located in the mildly tortuous, moderately calcified, and 14mm in diameter iliac vessel.The lesion contained <=45 degrees bend.A 14-4/5.8/120 xxl vascular balloon catheter was advanced for dilation.However, it was noted that the balloon was broken.The device was removed and the procedure was completed with a different device.No patient complications were reported and the patients status was stable.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that shaft break occurred.Vascular access was obtained via the left side.The 60% stenosed, 60mm in length, concentric, de novo target lesion was located in the mildly tortuous, moderately calcified, and 14mm in diameter iliac vessel.The lesion contained less than 45 degrees bend.A 14-4/5.8/120 xxl vascular balloon catheter was advanced for dilation.However, it was noted that the balloon was broken.The device was removed and the procedure was completed with a different device.No patient complications were reported and the patients status was stable.It was further reported that the shaft was not broken but the balloon ruptured.On initial inflation the balloon went down and could not be inflated anymore.The device was completely removed from the patient.A 16-4/5.8/120 xxl esophageal balloon catheter was also advanced for dilation but also ruptured.The device was completely removed from the patient and another balloon completed the procedure.The patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: a visual and microscopic examination was performed on the returned xxl device.A visual examination identified that the balloon was unfolded which indicates that the balloon had been subjected to positive pressure.The device was attached to an encore inflation unit and positive pressure was applied when liquid was observed escaping from a balloon pinhole leak approximately 15mm distal to the distal edge of the proximal markerband.The balloon material was visually and microscopically examined and no issues were noted that could have contributed to the complaint incident.No damage or any issues were noted along the length of the shaft that could have contributed to the complaint incident.An examination of the markerbands and tip identified no issues that could have potentially contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred.Vascular access was obtained via the left side.The 60% stenosed, 60mm in length, concentric, de novo target lesion was located in the mildly tortuous, moderately calcified, and 14mm in diameter iliac vessel.The lesion contained <=45 degrees bend.A 14-4/5.8/120 xxl vascular balloon catheter was advanced for dilation.However, it was noted that the balloon was broken.The device was removed and the procedure was completed with a different device.No patient complications were reported and the patients status was stable.It was further reported that the shaft was not broken but the balloon ruptured.On initial inflation the balloon went down and could not be inflated anymore.The device was completely removed from the patient.A 16-4/5.8/120 xxl esophageal balloon catheter was also advanced for dilation but also ruptured.The device was completely removed from the patient and another balloon completed the procedure.The patient was fine.

• 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: 8019603
• Report Number: 2134265-2018-62385
• Device Sequence Number: 19242440
• Product Code: LIT
• UDI-Device Identifier: 08714729190479
• UDI-Public: 08714729190479
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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,Followup
• Report Date (Section B): 01/11/2019

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: 12/09/2019
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0020059935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 11/05/2018; 12/17/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 11/28/2018; 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 56