MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) CRE¿ FIXED WIRE; DILATOR, ESOPHAGEAL

Model Number M00558340

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 04/13/2018

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown; however, it was reported the device was not used past its expiry date.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 esophagus during an esophagogastroduodenoscopy (egd) with balloon dilation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, a benign stricture was dilated and a perforation occurred.The perforation was then sealed and treated using a fully covered plastic stent.The procedure was not completed due to this event.Reportedly, there was no malfunction of the balloon, and the physician does not believe the perforation was caused by the balloon.In the physician¿s assessment, it is unknown what caused the perforation.The patient's condition at the conclusion of the procedure was reported to be doing well.

• Brand Name: CRE¿ FIXED WIRE
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7482675
• MDR Text Key: 107205281
• Report Number: 3005099803-2018-01330
• 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: Physician
• Type of Report: Initial
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00558340
• Device Catalogue Number: 5834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2018
• 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): Required Intervention
• Patient Age: 80 YR