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

Model Number	M00558930
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx biliary dilatation balloon was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2022.During the procedure, it was noted that the balloon did not hold pressure and the popped on the elevator.The procedure was completed with another cre rx biliary dilatation balloon.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx biliary dilatation balloon was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2022.During the procedure, it was noted that the balloon did not hold pressure and the popped on the elevator.The procedure was completed with another cre rx biliary dilatation balloon.There were no patient complications reported as a result of this event.Additional information received on july 13, 2022.It was clarified that the balloon did not burst but instead the balloon had pinhole.
Additional Manufacturer Narrative
Block h2: additional information: block b5 (describe event or problem) and h6 (device codes).Block h10: investigation results the returned cre rx biliary dilatation balloon was analyzed and a visual examination found that the catheter was kinked approximately 5.5cm from the bifurcation.No damages were found on the balloon.A functional evaluation was performed by attaching the device to an alliance inflation system.The balloon was inflated without a problem and no damages were found.With all the available information, boston scientific concludes the reported event of balloon pinhole was not confirmed.No damages were found on the returned balloon and it inflated properly during functional testing.Therefore, the most probable root cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.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.

• Brand Name: CRE RX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14633955
• Report Number: 3005099803-2022-03220
• Device Sequence Number: 5917751
• Product Code: FGE
• UDI-Device Identifier: 08714729965480
• UDI-Public: 08714729965480
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2022

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: 11/09/2024
• Device Model Number: M00558930
• Device Catalogue Number: 5893
• Device Lot Number: 0028535951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown