MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO GI; DILATOR, ESOPHAGEAL

Model Number M00558790

Device Problems Burst Container or Vessel (1074); Material Deformation (2976)

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

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used during gastrointestinal dilation procedure performed on an unknown date.During the procedure, the balloon ruptured on the second inflation.The procedure was completed at this time.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used during gastrointestinal dilation procedure performed on an unknown date.During the procedure, the balloon ruptured on the second inflation.The procedure was completed at this time.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b3: date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.Block h6: device code a0402 captures the reportable event of balloon burst.Block h10: investigation result: a visual examination of the returned complaint device found that the balloon and the catheter of the device did not have any damages.Microscopic analysis was performed, it was noticed that thte balloon had an irregular shape in the distal side.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 distal section on the body of the balloon.This does not confirm the reported event of balloon burst.The pinhole problem is likely due to factors encountered during the procedure, such as the that interaction with scope or any other surface during the procedure that could have created friction, resulting in the found failure of balloon pinhole.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.

• Brand Name: CRE PRO GI
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12205149
• MDR Text Key: 262735372
• Report Number: 3005099803-2021-03606
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Model Number: M00558790
• Device Catalogue Number: 5879
• Device Lot Number: 0027073291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1