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

Model Number	M00558630
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).Investigation result: a visual examination of the returned complaint device found that the balloon.The catheter was noted to be kinked.Microscopic analysis was performed, and it was noticed that the balloon had a pinhole, which confirms the reported event of the balloon leaked.During the microscope inspection the balloon was dissected to inspect the ro markers (distal- medium-proximal) and no defects were noted.Functional evaluation was performed, and the balloon was inflated without problem; however, the balloon would not hold pressure due to a pinhole located in the proximal section on the body of the balloon.This problem is likely due to factors encountered during the procedure, such as the interaction between the balloon and the scope or any other surface during the procedure that could have created friction, resulting in the found failure of balloon pinhole.Additionally, the catheter kink may be related to some factors such as; handling of the device, the technique used by the physician, the interaction with the scope and normal procedural difficulties encountered during the procedure could have affected the device.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 pro wireguided dilatation balloon was used in the duodenal papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the esophagus on (b)(6) 2021.During the procedure, it was noted that the balloon was leaking water and it could not be inflated.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation finding of balloon pinhole.

• Brand Name: CRE PRO
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12350478
• Report Number: 3005099803-2021-04311
• Device Sequence Number: 17466032
• Product Code: FGE
• UDI-Device Identifier: 08714729797517
• UDI-Public: 08714729797517
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2021

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: 12/15/2021
• Device Model Number: M00558630
• Device Catalogue Number: 5863
• Device Lot Number: 0023189667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 60