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

Model Number M001145530

Device Problems Balloon (419); Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2016

Event Type  Malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older. 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

It was reported that balloon pinhole occurred. Vascular access was obtained via the femoral artery. The 16mm in diameter target lesion was located in a non-tortuous and non-calcified vein. A 16-4/5. 8/120 xxl¿ esophageal balloon catheter was advanced for dilatation. However, during the first inflation at 4 atmospheres for 60 seconds, the balloon was noted to be leaking and did not fully inflate. The balloon was then deflated and blood was found in the inflation device. The physician felt there were some holes in the balloon. No patient complications were reported and the patient's status was stable.

• 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: 5546998
• MDR Text Key: 41894151
• Report Number: 2134265-2016-02452
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (Y/N): N
• Reporter Country Code: IN
• PMA/PMN Number: K952656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,DISTRI

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/08/2016

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 04/05/2016
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 03/18/2017
• Device MODEL Number: M001145530
• Device Catalogue Number: 14-553
• Device LOT Number: 0016827415
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 03/21/2014
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial