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

Model Number M00558740

Device Problems Entrapment of Device (1212); Use of Device Problem (1670); Material Twisted/Bent (2981)

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

Event Date 03/08/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used in the esophagus during an endoscopic esophageal dilatation procedure performed on (b)(6) 2022.Prior the procedure, an inflation and deflation of the device was performed for external confirmation purposes.The device was then inserted in the endoscopic forceps channel; however, severe resistance was felt midway.Reportedly, the device was removed and checked by the physician, it was noted that when the guidewire of the balloon part was pulled into the hand base the part without guidewire, the tip of the balloon, was significantly bent.The procedure was completed with a different device.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Block e1: initial reporter facility name: (b)(6).Block h6: problem code a040609 captures the reportable event of balloon tip bent.Block h10: investigation result a visual examination of the returned complaint device found that the balloon and the catheter of device had no damages, which does not confirm the reported event of balloon tip bent.The guidewire lumen was stretched and kinked at the balloon section.It was also found that the guidewire was unraveled.Functional evaluation was performed by withdrawing the guidewire and found entrapment at the guidewire lumen in the balloon section.This problem is likely due to factors or conditions related to the procedure during the use of the device, such as the guidewire entrapment in the guidewire lumen.This entrapment is likely to have occurred due to the guidewire unraveled found in the device.That condition in the guidewire provokes friction in the lumen causing the guidewire lumen to be stretched and kinked.Factors encountered during the procedure could provoke that the guidewire unraveled, the manner as the device was handled and manipulated may have caused the reported and encountered failure.Excessive manipulation of the device without enough care could have induced the problem found.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 not used per the directions for use (dfu)/product label as the balloon was pre-inflated.

Event Description

It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used in the esophagus during an endoscopic esophageal dilatation procedure performed on (b)(6) 2022.Prior the procedure, an inflation and deflation of the device was performed for external confirmation purposes.The device was then inserted in the endoscopic forceps channel; however, severe resistance was felt midway.Reportedly, the device was removed and checked by the physician, it was noted that when the guidewire of the balloon part was pulled into the hand base the part without guidewire, the tip of the balloon, was significantly bent.The procedure was completed with a different device.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.There were no patient complications reported as a result of this event.

• Brand Name: CRE PRO GI
• Type of Device: DILATOR, ESOPHAGEAL
• 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: 13996295
• MDR Text Key: 288504685
• Report Number: 3005099803-2022-01609
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2024
• Device Model Number: M00558740
• Device Catalogue Number: 5874
• Device Lot Number: 0027152791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2021
• 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