MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE FIXED WIRE; DILATOR, ESOPHAGEAL

Model Number M00558380

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to report the device lot number; therefore the manufacture date and expiration date are unknown.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the trachea during an airway dilation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, a tear was visualized on the trachea of the patient after balloon dilation had been completed and the balloon was removed.Reportedly, it was not certain what exactly caused of the injury, and there was no malfunction of the cre balloon reported.The procedure was completed at this time, and the patient was monitored overnight and eventually sent home with restrictions on the amount of weight that could be lifted.Per the directions for use (dfu), the cre fixed wire dilation balloon is intended to endoscopically dilate strictures of the esophagus and is not intended for use in the trachea.

• Brand Name: CRE FIXED WIRE
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8202365
• MDR Text Key: 131590379
• Report Number: 3005099803-2018-62179
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729202011
• UDI-Public: 08714729202011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971320
• 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: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00558380
• Device Catalogue Number: 5838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2018
• 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
• Patient Outcome(s): Hospitalization