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

Model Number	M00558670
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the duodenum during a cholangio-pancreatographie retrograde endoscopique (cpre) procedure on (b)(6) 2022.During the procedure, the balloon was inflated to the recommended pressure; however, the balloon burst.The customer stated that nothing detached into the patient.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure on december 19, 2022.During the procedure, the balloon was inflated to the recommended pressure; however, the balloon burst.The customer stated that nothing detached into the patient.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h2: correction: block b5 (describe event or problem).Block h6: imdrf device code a0402 captures the reportable event of balloon burst.Block h10: investigation results- the returned cre pro wireguided dilatation balloon was analyzed and a visual and microscopic examination found the balloon was detached and was not returned.No damages were found on the catheter of the device.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of balloon burst was not confirmed as the balloon was detached and not returned.The balloon was found to be detached, likely due to factors encountered during the procedure, such as excess pressure, the interaction with other devices or anatomical affairs.However, it is possible that interaction with any surface during the procedure could have created friction, causing the balloon to be detached.Therefore, the most probable root cause is adverse event related to procedure.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 PRO
• 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: 16134112
• Report Number: 3005099803-2022-08034
• Device Sequence Number: 20742264
• Product Code: FGE
• UDI-Device Identifier: 08714729797555
• UDI-Public: 08714729797555
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K112994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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: 02/08/2025
• Device Model Number: M00558670
• Device Catalogue Number: 5867
• Device Lot Number: 0029028483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• 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 Age: 59 YR
• Patient Sex: Male