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

Model Number M00558360

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/14/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of balloon catheter break.

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 catheter broke into two separate pieces making it difficult to remove the balloon.The customer stated that no pieces of the device detached inside the patient.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications 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 esophageal dilation procedure performed on (b)(6), 2023.During the procedure, the catheter broke into two separate pieces making it difficult to remove the balloon.The customer stated that no pieces of the device detached inside the patient.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of balloon catheter break.Block h10: investigation results: the returned cre fixed wire dilatation balloon was analyzed, and a visual examination found that the catheter was kinked.Microscopic examination was performed and found that the catheter was kinked.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of catheter break was not confirmed.It was found that the catheter was kinked, not separated, or broken.Excessive manipulation of the device without enough care, excessive force during handling or usage, and/or forcing the device against significant resistance could induce device damages or loss of functionality.As the catheter break was not confirmed, 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17690617
• MDR Text Key: 322733528
• Report Number: 3005099803-2023-04706
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• 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: 0030531112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2022
• 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