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

Model Number M00558360

Device Problems Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a041001 captures the reportable event of balloon pinhole in the esophagus.

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 (b)(6) 2023.During the procedure, the cre fixed wire balloon was inflated successfully to 12 mm, then to 13.5 mm.However, when it was inflated to 15mm the balloon ruptured and was no longer able to be inflated.The balloon was then removed from the scope; upon inspection, the balloon was intact with the exception of a hole at the end of the balloon.The procedure was completed with the original device.There were no patient complications reported as a result of this event.

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 (b)(6) 2023.During the procedure, the cre fixed wire balloon was inflated successfully to 12 mm, then to 13.5 mm.However, when it was inflated to 15mm the balloon ruptured and was no longer able to be inflated.The balloon was then removed from the scope; upon inspection, the balloon was intact with the exception of a hole at the end of the balloon.The procedure was completed with the original device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a041001 captures the reportable event of balloon pinhole in the esophagus.Block h10: investigation results: the returned cre fixed wire dilatation balloon was analyzed, and a visual examination found that the balloon had a hole.Microscopic inspection found a rupture from the distal tip until the mid-section of the balloon.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon pinhole cannot be confirmed.The balloon had a rupture instead of a pinhole.The rupture found in the balloon is likely to have occurred due to factors encountered during the procedure, it can be due to excess pressure, interaction with other devices, or anatomical factors.These factors and interactions could influence the damage found in the balloon.Also, it is possible that interaction with any kind of sharp surface during/previous the procedure could create friction on the balloon, causing the analyzed problem during the procedure.Therefore, the most probable root cause is an adverse event related to procedure.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17490622
• MDR Text Key: 320870648
• Report Number: 3005099803-2023-04198
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729195986
• UDI-Public: 08714729195986
• 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: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558360
• Device Catalogue Number: 5836
• Device Lot Number: 0029757198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2022
• 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 Age: 66 YR
• Patient Sex: Female