MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE RX; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00558880
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Manufacturer report # 3005099803-2018-61371 pertains to the first cre rx dilatation balloon, and manufacturer report # 3005099803-2018-61367 pertains to the second cre rx dilatation balloon.It was reported to boston scientific corporation that two cre rx dilatation balloon were used in the stomach during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, it was noted that there was difficulty in advancing the device down the scope.Reportedly, the device got stuck in the working channel and they had trouble getting it out.It was then that the catheter snapped.None of the catheter was inside the patient.The scope was taken out of the patient, and the device was removed from the scope.The same issue occurred with the second cre rx dilatation balloon.The procedure was completed with another cre rx dilatation balloon.There were no patient complications reported as a result of this event.

• Brand Name: CRE RX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8086656
• Report Number: 3005099803-2018-61367
• Device Sequence Number: 19227332
• Product Code: FGE
• UDI-Device Identifier: 08714729965435
• UDI-Public: 08714729965435
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2018

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: 08/29/2020
• Device Model Number: M00558880
• Device Catalogue Number: 45767
• Device Lot Number: 0021193735
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1