MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE FIXED WIRE; DILATOR, ESOPHAGEAL

Model Number M00558380

Device Problems Break (1069); Deflation Problem (1149); Use of Device Problem (1670)

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

Event Date 09/28/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (egd) with dilation procedure performed on (b)(6) 2022.During withdrawal, when the tech tried to deflate the balloon, it would not deflate completely.The physician then pulled the balloon back into the scope before it was fully deflated, causing a piece of the catheter to break off inside the patient and had to be retrieved with a rescue net.Additionally, the balloon would not come out of the scope so the technician and nurse cut the catheter into two pieces to remove from the scope.Since this occurred during withdrawal, the procedure had already been completed with the original device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: device code a0401 captures the reportable event of catheter break.Device code a1401 captures the reportable event of balloon failed to deflate.

Event Description

It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (egd) with dilation procedure performed on (b)(6) 2022.During withdrawal, when the tech tried to deflate the balloon, it would not deflate completely.The physician then pulled the balloon back into the scope before it was fully deflated, causing a piece of the catheter to break off inside the patient and had to be retrieved with a rescue net.Additionally, the balloon would not come out of the scope so the technician and nurse cut the catheter into two pieces to remove from the scope.Since this occurred during withdrawal, the procedure had already been completed with the original device.There were no patient complications reported as a result of this event.Correction: note: the instructions for use (ifu) indicate that this balloon should be fully deflated before withdrawal.However, the customer reported that the balloon was not fully deflated upon withdrawal from the patient.

• Brand Name: CRE FIXED WIRE
• 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: 15701142
• MDR Text Key: 302718318
• Report Number: 3005099803-2022-06291
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729202011
• UDI-Public: 08714729202011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2024
• Device Model Number: M00558380
• Device Catalogue Number: 5838
• Device Lot Number: 0028941471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• 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 Outcome(s): Required Intervention