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

Model Number M00558430

Device Problems Difficult to Remove (1528); Use of Device Problem (1670); Material Twisted/Bent (2981)

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

Event Date 02/14/2023

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Imdrf device code a040609 captures the reportable event of tip bent.

Event Description

It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the esophagus during a procedure performed on (b)(6) 2023.During the withdrawal, the balloon was unable to be pulled through the scope.The physician cut the balloon for removal from the scope and noticed the distal end of the balloon tip was bent.The physician noted that the balloon was not adequately deflated when it was being pulled through the scope.The procedure was completed with the original device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Note: the instructions for use (ifu) indicate that this balloon should be completely deflated prior to removing the device from the scope.However, the customer reported that the balloon was not completely deflated during removal.

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 a040609 captures the reportable event of tip bent.Block h10: investigation result the returned cre wireguided dilatation balloon was analyzed, and a visual examination found that the balloon was detached and not returned.The catheter of the device was carefully inspected and no damages were found.Microscopic inspection found that the wire was bent.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of tip bent was not confirmed as the tip was not returned.The customer reported that the balloon was not adequately deflated before withdrawing the device from the endoscope.The instructions for use (ifu) for the device states, "precaution: do not pull back on the catheter until the balloon is deflated completely.Warning: the balloon must be thoroughly deflated and all fluid removed prior to withdrawal".Based on the analysis performed and all the information gathered from the customer, the overall conclusion code assigned will be failure to follow instruction because the user did not follow the manufacturer instructions.Ship history review was performed to identify the most probable lot numbers and a manufacturing review of the most probable lot numbers did not identify any anomalies or deviations that could have contributed to the event.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the esophagus during a procedure performed on (b)(6) 2023.During the withdrawal, the balloon was unable to be pulled through the scope.The physician cut the balloon for removal from the scope and noticed the distal end of the balloon tip was bent.The physician noted that the balloon was not adequately deflated when it was being pulled through the scope.The procedure was completed with the original device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Note: the instructions for use (ifu) indicate that this balloon should be completely deflated prior to removing the device from the scope.However, the customer reported that the balloon was not completely deflated during removal.

• Brand Name: CRE WIREGUIDED
• 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: 16507359
• MDR Text Key: 311332223
• Report Number: 3005099803-2023-01144
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729339366
• UDI-Public: 08714729339366
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558430
• Device Catalogue Number: 5843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• 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