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

Model Number M00558370

Device Problems Deflation Problem (1149); Inflation Problem (1310); Failure to Deflate (4060)

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

Event Date 09/22/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Note: this report pertains to one of two cre fixed wire dilatation balloon used during the same procedure.It was reported to boston scientific corporation that two cre fixed wire dilatation balloon were used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2022.During the procedure, it was noted that both balloons did not inflate or deflate properly.The procedure was completed with the second cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.

Event Description

Note: this report pertains to one of two cre fixed wire dilatation balloon used during the same procedure.It was reported to boston scientific corporation that two cre fixed wire dilatation balloon were used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6), 2022.During the procedure, it was noted that both balloons did not inflate or deflate properly.The procedure was completed with the second cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h2: correction: block d7a (sud reprocessed and reused) and h8 (usage of device) block h6: device code a140101 captures the reportable event of balloon failure to deflate.Block h10: investigation result the returned cre fixed wire dilatation balloon was analyzed and a visual examination found the catheter was kinked 30cm from the balloon and the balloon was found torn circumferentially.Microscopic examination confirmed the circumferential tear located approximately at 10mm from the tip of the device.The tip of the balloon was not returned.A functional inspection could not be performed due to the returned condition of the device.No other problems with the device were noted.It was reported that the balloon could not be deflated during the procedure but, this could not be confirmed as the balloon was torn circumferentially and a functional analysis was not possible.It is possible that factors encountered during the procedure, such as the excess pressure, interaction with other devices, or anatomical affairs could cause physical damage to the balloon.It is possible that interaction with any surface during the procedure could create friction on the balloon, causing it to tear circumferentially during the procedure.Also, it is possible that interaction with any kind of a sharp surface during or previous to the procedure could create friction on the balloon, causing the balloon to be torn circumferentially.Therefore, the most probable root cause of the balloon failing to deflate is cause not established.

• 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: 15632425
• MDR Text Key: 307161168
• Report Number: 3005099803-2022-06094
• Device Sequence Number: 1
• Product Code: KNQ
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

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: 01/10/2024
• Device Model Number: M00558370
• Device Catalogue Number: 5838
• Device Lot Number: 0028650665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/19/2022
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2022
• 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