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

Model Number M00558470

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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 wireguided dilatation balloon was used during an esophageal dilatation procedure performed on an (b)(6) 2017.According to the complainant, during the preparation, the balloon was not in a tight wingfolded position once the wingtool was removed from the balloon and it was unable to fit through the biopsy cap.It was also reported that the distal tip of the catheter was bent.The procedure was completed with another cre wireguided dilatation 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 stable.

• Brand Name: CRE¿ WIREGUIDED
• 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: 7138201
• MDR Text Key: 95610712
• Report Number: 3005099803-2017-03921
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729339403
• UDI-Public: 08714729339403
• Combination Product (y/n): N
• Reporter Country Code: ZA
• PMA/PMN Number: K110833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: M00558470
• Device Catalogue Number: 5847
• Device Lot Number: 0017974732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2015
• 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 Weight: 80