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

Model Number	M00558430
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005099803-2023-01144
• Device Sequence Number: 3353924
• Product Code: KNQ
• UDI-Device Identifier: 08714729339366
• UDI-Public: 08714729339366
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown