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

Model Number M00558380

Device Problems Break (1069); Deflation Problem (1149); Difficult to Remove (1528)

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

Event Date 08/15/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophageal stenosis dilatation (esd) procedure performed on (b)(6) 2022.During withdrawal, it was noticed that the balloon could not be deflated after the second inflation at 3atm, and the device could not be removed from the endoscope.The device together with the entire endoscope was then removed from the patients body; however, the shaft at the base of the balloon was separated.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications have been reported due to 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 stenosis dilatation (esd) procedure performed on (b)(6) 2022.During withdrawal, it was noticed that the balloon could not be deflated after the second inflation at 3atm, and the device could not be removed from the endoscope.The device together with the entire endoscope was then removed from the patients body; however, the shaft at the base of the balloon was separated.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications have been reported due to this event.

Manufacturer Narrative

Block e1: (b)(6).Block h6: device code a0401 captures the reportable event of catheter break.Device code a1401 captures the reportable event of balloon failed to deflate.Block h10: investigation results: the returned cre fixed wire dilatation balloon was analyzed and a visual examination found the catheter was detached and the balloon was torn circumferentially.With all the available information, boston scientific concludes the reported event of catheter break was confirmed as the catheter was detached.However, the reported event of balloon failure to deflate could not be confirmed as the balloon was torn and not able to be functionally tested.It is possible that procedural factors could cause the balloon to be difficult to remove from the device.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

• 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: 15331699
• MDR Text Key: 302070314
• Report Number: 3005099803-2022-04976
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729202011
• UDI-Public: 08714729202011
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

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: 03/01/2024
• Device Model Number: M00558380
• Device Catalogue Number: 5838
• Device Lot Number: 0028967118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 09/14/2022
• Supplement Dates FDA Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2022
• 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