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

Model Number M00558700

Device Problem Leak/Splash (1354)

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

Event Date 01/20/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during a esophagogastroduodenoscopy (egd) with dilation procedure performed on (b)(6) 2023.During the procedure, the physician placed the balloon in the stenosis and started filling the balloon to reach 3 atm.However, liquid was coming out of one side of the balloon and no further movement on the manometer was observed.The physician removed the endoscope with the balloon from the patient and observed liquid coming out of the balloon.The balloon was removed from the endoscope and 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's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Imdrf device code a0504 captures the reportable event of balloon leaked in the esophagus.

Event Description

It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during a esophagogastroduodenoscopy (egd) with dilation procedure performed on (b)(6) 2023.During the procedure, the physician placed the balloon in the stenosis and started filling the balloon to reach 3 atm.However, liquid was coming out of one side of the balloon and no further movement on the manometer was observed.The physician removed the endoscope with the balloon from the patient and observed liquid coming out of the balloon.The balloon was removed from the endoscope and 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's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a0504 captures the reportable event of balloon leaked in the esophagus.Block h10: investigation results the returned cre pro wireguided dilatation balloon was analyzed, and a visual examination found that the balloon and catheter of the device had no damages.Functional analysis was performed, and the balloon was inflated without a problem.However, the balloon would not hold pressure due to a pinhole in the proximal section.Microscopic inspection found the balloon had a pinhole located approximately 75mm from the tip.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event balloon leak was confirmed.The pinhole problem found could have been interpreted by the customer as the reported event of balloon leak.The balloon pinhole is likely to have occurred due to factors encountered during the procedure: excess pressure, interaction with other devices, or patient anatomy.It is possible that factors encountered during the procedure, such as the interaction with scope or any other surface during the procedure could create friction on the balloon and cause a leak on the balloon.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 directions for use (dfu) / product label.

• 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: 16386651
• MDR Text Key: 309903010
• Report Number: 3005099803-2023-00718
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729797586
• UDI-Public: 08714729797586
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 04/24/2023

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
• Device Operator: Health Professional
• Device Model Number: M00558700
• Device Catalogue Number: 5870
• Device Lot Number: 0030322258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2022
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 63 KG