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

Model Number	M00558470
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 7138201
• Report Number: 3005099803-2017-03921
• Device Sequence Number: 16164529
• Product Code: KNQ
• UDI-Device Identifier: 08714729339403
• UDI-Public: 08714729339403
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K110833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2017

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 80