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

Model Number M001145570

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.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).

Event Description

Same case as mdr id 2134265-2015-05250, 2134265-2015-05788 and 2134265-2015-05902.It was reported that a balloon marking issue occurred.The target lesion was located in the iliac vein.A 18x40mm wallstent was deployed and post-dilated with good result.A second 18x40mm wallstent was deployed overlapping proximal to the previous stent.During post-dilation with two 18x40mm xxl esophageal balloon catheters, the physician noted that both balloons looked funny and inflated first at the "shoulders" way beyond the marks.During dilation the stent "jumped" about an inch and a half which made it to go into the inferior vena cava and no longer overlapping the previous stent.The procedure was concluded.Two days following the initial procedure the patient returned to the hospital due to swelling of the leg.Two balloon expandable stents were deployed inside the implanted wallstents.No further patient complications were reported.

• Brand Name: XXL¿ ESOPHAGEAL
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5001838
• MDR Text Key: 22947796
• Report Number: 2134265-2015-05789
• 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
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001145570
• Device Catalogue Number: 14-557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: XXL¿ ESOPHAGEAL