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

Model Number M00558610

Device Problems Leak/Splash (1354); Material Rupture (1546)

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

Event Date 04/18/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: the returned cre pro wireguided dilatation balloon was analyzed and a visual examination found no damages to the catheter or balloon of the device.A functional inspection was performed by connecting the device to an alliance inflation system.The balloon inflated without problem, however, it did not hold pressure due to a rupture in the proximal section.The rupture was confirmed via microscopic inspection and noted to be located 66 mm from the tip.With all the available information, boston scientific concludes the reported event was not confirmed.The rupture found in the balloon is likely to have occurred due to factors encountered during the procedure; excess pressure, interaction with other devices, or anatomical affairs.It is possible that factors encountered during the procedure, such as the interaction with any surface, could create friction on the balloon and cause a leak during the procedure.Therefore, the most probable root cause is adverse event related to procedure.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.

Event Description

It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, it was noted that the balloon could not be inflated.Observation under the endoscope showed that the balloon leaked.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 reportable based on the investigation results of balloon ruptured.

• 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: 15126600
• MDR Text Key: 304024289
• Report Number: 3005099803-2022-04097
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729797494
• UDI-Public: 08714729797494
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2023
• Device Model Number: M00558610
• Device Catalogue Number: 5861
• Device Lot Number: 0026031447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2020
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 63 KG