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

Model Number	M00558870
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.(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
It was reported to boston scientific corporation that a cre rx dilatation balloon was used in the common bile duct (cbd) during a sphincteroplasty of the ampulla procedure performed on an unknown date.According to the complainant, during the procedure, the balloon burst when attempting to dilate the cbd; it was noticed that the balloon burst at roughly 9.5mm.Reportedly, the stones were small and were not hard or sharp.No part of the balloon detached inside the patient.The balloon was then removed from the patient and the procedure was completed with another cre rx dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.Block h6: problem code 1074 captures the reportable issue of balloon burst.Block h10: investigation results a visual examination of the returned complaint device revealed that the balloon was ruptured in the middle section on the body of the balloon and the other section was not returned.It was also noted that the detached part has a jagwire guidewire stuck inside.No damage found on the catheter of the device.The failure found confirms the reported event.This failure is likely due to factors or conditions related to the procedure that could have affected its performance and its intended purpose, such as the technique used by the physician and/or the interaction with the scope when the physician advanced the balloon could have caused the balloon to burst during the procedure.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx dilatation balloon was used in the common bile duct (cbd) during a spincteroplasty of the ampulla procedure performed on an unknown date.According to the complainant, during the procedure, the balloon burst when attempting to dilate the cbd; it was noticed that the balloon burst at roughly 9.5mm.Reportedly, the stones were small and were not hard or sharp.No part of the balloon detached inside the patient.The balloon was then removed from the patient and 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: 11064629
• Report Number: 3005099803-2020-06268
• Device Sequence Number: 19472894
• Product Code: FGE
• UDI-Device Identifier: 08714729965428
• UDI-Public: 08714729965428
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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: 07/14/2023
• Device Model Number: M00558870
• Device Catalogue Number: 45767
• Device Lot Number: 0025858921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1