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

Model Number	M00558410
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Initial reporter facility name: (b)(6) medical university.(b)(4).Investigation result: a visual examination of the returned complaint device found that the balloon and the catheter did not have any damages.Functional evaluation was performed, and the balloon was inflated without problem; however, the balloon would not hold pressure due to two pinholes located in the proximal section on the body of the balloon.This confirms the reported event of the balloon was cracked.The pinhole problem is likely due to factors encountered during the procedure, such as the technique used by the physician and/or the interaction with the scope when the physician advanced the balloon could have caused that the balloon burst during the procedure.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 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 common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) with calculus removal procedure performed on (b)(6) 2021.During the procedure, they were able to cannulate the scope successfully.Based on the angiography showing stones in the upper middle section of the common bile duct, balloon inflation was needed.They injected liquid as required and leakage was noticed in the balloon; hence, they could not dilate papilla.They removed the balloon and it was found that the balloon was cracked.The procedure was completed with another cre wireguided dilation balloon.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.

• 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: 12344511
• Report Number: 3005099803-2021-04142
• Device Sequence Number: 14586721
• Product Code: KNQ
• UDI-Device Identifier: 08714729339342
• UDI-Public: 08714729339342
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/19/2021

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: 03/24/2023
• Device Model Number: M00558410
• Device Catalogue Number: 5841
• Device Lot Number: 0025464813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1