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

Model Number M00558380

Device Problems Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/02/2023

Event Type  malfunction  

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.

Event Description

It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophageal dilation procedure performed on (b)(6) 2023.During the procedure, the balloon burst and started leaking fluid.The customer stated that no pieces of the balloon detached inside the patient.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophageal dilation procedure performed on (b)(6)2023.During the procedure, the balloon burst and started leaking fluid.The customer stated that no pieces of the balloon detached inside the patient.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

H10: block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h10: investigation results: the returned cre fixed wire dilatation balloon was analyzed, and a visual examination found that the balloon had no damages, and the catheter was kinked in several sections.Microscopic examination was performed and confirmed that the catheter was kinked in several sections.Functional analysis was performed, and the balloon was inflated and able to hold pressure without any problem.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.The returned device was in good condition with the capability of being inflated and holding pressure without evidence of leaking.There was no evidence of any damages or issues that would indicate a problem with the device.Therefore, the most probable root cause is no problem detected.

• 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: 17599801
• MDR Text Key: 321971856
• Report Number: 3005099803-2023-04461
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558380
• Device Catalogue Number: 5838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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