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

Model Number M001145140

Device Problems Material Rupture (1546); Torn Material (3024)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

It was reported that balloon rupture and balloon tear occurred.The target lesion was located in an unspecified graft in the arm.A xxl/14-4/5.8/75 xxl vascular balloon catheter was advanced to the target lesion for dilation of a previously implanted unspecified stent with in-stent restenosis.However the balloon ruptured transverse and was torn circumferentially.The balloon effectively opened the vessel before it ruptured.About 2/3 of the balloon was successfully removed.The remaining fragment was crushed against the graft wall with an unspecified covered stent which was dilated to 8mm.It was suspected that much of the damage on the balloon occurred due to unsuccessful efforts to remove the torn balloon through the unspecified sheath.No patient complications were reported.The patient's status was good with resolved arm swelling.

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• Brand Name: XXL? VASCULAR
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3634146
• MDR Text Key: 3989651
• Report Number: 2134265-2014-00689
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2016
• Device Model Number: M001145140
• Device Catalogue Number: 14-514
• Device Lot Number: 0016543120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention