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

Model Number M00558630

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2021

Event Type  malfunction  

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 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
• Type of Device: 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: 12350478
• MDR Text Key: 267623546
• Report Number: 3005099803-2021-04311
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729797517
• UDI-Public: 08714729797517
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K112994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 60