MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY XXL¿ VASCULAR; DILATOR, ESOPHAGEAL

Model Number M001145140

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).  device evaluated by mfr.: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.  bsc id: (b)(4).Tw: (b)(4).

Event Description

It was reported that balloon rupture, catheter removal difficulties were encountered and balloon detachment occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified subclavian vein in the left arm.A 14-4/5.8/75cm xxl¿ vascular balloon catheter was advanced to dilate the lesion.However, during the first inflation at 6 atmospheres, balloon ruptured.Difficulties were encountered while pulling the device out of the sheath and it was noted that some of the balloon fragment shattered off into the patient's vein.A pair of hemostat was used to retrieve the fragments completely out of the patient's body.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.

• Brand Name: XXL¿ VASCULAR
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7656932
• MDR Text Key: 112993046
• Report Number: 2134265-2018-05878
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2021
• Device Model Number: M001145140
• Device Catalogue Number: 14-514
• Device Lot Number: 0021749112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR