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

Model Number	M00558390
Medical Device Problem Codes	Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).Investigation result: a visual examination of the returned complaint device found that the catheter of device was free of obvious kinks and bends and no visual issues were identified with the balloon.Microscopic analysis was performed, and it was noticed that the balloon had a pinhole.Functional evaluation was performed and the balloon was inflated without problem; however, the balloon would not hold pressure due to the pinhole located at the proximal section of the balloon.Based on the available information, it is possible that factors encountered during the procedure, such as procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity.It is likely that interaction with scope, other devices/tools or any other surface during the procedure could create friction on the balloon, causing the pinhole in the device leading to inflation issues.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
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) procedure performed on (b)(6) 2021.During the procedure, the balloon was attempted to be inflated; however, it was noticed that the balloon could not be fully inflated.The procedure was completed with another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event, and the patient condition following the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation finding of 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: 12374820
• Report Number: 3005099803-2021-04441
• Device Sequence Number: 3935330
• Product Code: FDF
• UDI-Device Identifier: 08714729339328
• UDI-Public: 08714729339328
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/26/2021

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: 12/02/2023
• Device Model Number: M00558390
• Device Catalogue Number: 5839
• Device Lot Number: 0026570973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 54