MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK CRE? FIXED WIRE; DILATOR, ESOPHAGEAL

Model Number M00558380

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a cre fixed wire balloon was used during an esophageal dilation procedure in the esophagus performed on (b)(6) 2014 according to the complainant, during the procedure the balloon did not advance through the working channel.The procedure was completed with another cre fixed wire balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.The investigation found the distal tip to be kinked; therefore, this is now an mdr reportable event.

Manufacturer Narrative

Reported event of distal tip kinked.The complaint sample was returned for evaluation.No wingtool was present, the balloon was wingfolded.Visual evaluation found the distal tip of the balloon to be kinked, and the catheter kinked.During functional evaluation, the unit was inserted into the scope and restriction was experienced at the kink in the distal tip.It was reported a vacuum was not applied prior to insertion, which may have caused difficulty during advancement through the scope, leading to the noted damage.The device history record review confirms that the device met all material, assembly and performance specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.

• Brand Name: CRE? FIXED WIRE
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3731662
• MDR Text Key: 4312100
• Report Number: 3005099803-2014-01659
• Device Sequence Number: 1
• Product Code: KNQ
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2015
• Device Model Number: M00558380
• Device Catalogue Number: 5838
• Device Lot Number: 0016333709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2014
• Initial Date FDA Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2013
• 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