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

Model Number M00558340

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: a visual examination of the returned complaint device found a kink in the distal tip and the protective sleeve.The balloon was folded and it did not show signs of use.The noted failure was most likely caused by handling of the device or portion of the device without direct patient contact either during unpacking, preparation, or shipping; therefore, the most probable root cause is handling damage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no other complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a cre fixed wire dilation balloon was used on a procedure performed on an unknown date.According to the complainant, the device was defective.There were no patient complications reported as a result of this event.Attempts to obtain additional patient and procedure information have been unsuccessful.Should additional relevant details become available, a supplemental report will be submitted.Investigation results revealed that the distal tip of the balloon was bent; therefore this is now an mdr reportable event.

• 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: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7761518
• MDR Text Key: 116386140
• Report Number: 3005099803-2018-02467
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729201991
• UDI-Public: 08714729201991
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2019
• Device Model Number: M00558340
• Device Catalogue Number: 5834
• Device Lot Number: 0020820724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1