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

Model Number	M00558470
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned cre wireguided balloon was analyzed, and a visual evaluation noted that no damages were found on the balloon and catheter of the device.A functional evaluation noted that the balloon was able to inflate but did not hold pressure due to a pinhole in the balloon.No other problems with the device were noted.Analysis of the returned device revealed a pinhole in the balloon material.The problem found could have been interpreted by the customer as the reported event of balloon leak.It is possible that interaction with scope or any other surface during the procedure could create friction on the balloon, causing the problem of "balloon pinhole" during the procedure.Therefore, the event is classified as "adverse event related to procedure" because, the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided balloon was used during a balloon dilatation procedure performed in the colon on (b)(6) 2021.During the procedure, it was noted that the balloon leaked.The user noted that there were no visible issues or damage to the balloon.The procedure was completed with another of the same 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 stable.This event has been deemed a reportable event based on the investigation which revealed a unreported failure mode: balloon pinhole.

• Brand Name: CRE WIREGUIDED
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11890340
• Report Number: 3005099803-2021-02455
• Device Sequence Number: 3399867
• Product Code: FDT
• UDI-Device Identifier: 08714729339403
• UDI-Public: 08714729339403
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2021

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 Expiration Date: 06/20/2023
• Device Model Number: M00558470
• Device Catalogue Number: 5847
• Device Lot Number: 0025739235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1