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

Model Number M00558370

Device Problem Deflation Problem (1149)

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

Event Date 03/01/2021

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).The device has not been received for analysis.Upon receipt and 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 fixed wire dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on an unknown date.During the procedure, the balloon was successfully dilated; however, the balloon could not be fully deflated and could not be withdrawn through the scope.Resultingly, the balloon ripped as soon as the catheter was pulled through the scope and left a bunched-up balloon on the end of the catheter which made it more difficult to remove the device from the scope.The scope had to be removed in order to remove the device inside, and another scope was used to complete the procedure.There were no patient complications as a result of this event.

• 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: 11607487
• MDR Text Key: 243546689
• Report Number: 3005099803-2021-01354
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729195993
• UDI-Public: 08714729195993
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2021

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: 10/17/2022
• Device Model Number: M00558370
• Device Catalogue Number: 5837
• Device Lot Number: 0026203396
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 04/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2020
• 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