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

Model Number	M00558420
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	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual inspection of the device revealed no damages on the catheter or balloon of the device.Functional testing of the device was able to inflate the balloon without problem; however, the balloon did not hold pressure due to the pinhole in the distal section on the body of the balloon.The analysis of the returned device confirmed the reported event.This problem could occur due to interaction with scope, the technique used by the physician or any other surface during the procedure could create friction on the balloon, causing a pinhole during the procedure.The most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.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 a balloon dilation assisted lithotomy procedure performed on (b)(6) 2021.During the procedure, the device was attempted to be inflated; however, the balloon could not inflate completely.The procedure was completed with another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Investigation results revealed that this balloon had a pinhole; therefore, this is now an mdr reportable event.

• 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: 12042468
• Report Number: 3005099803-2021-03001
• Device Sequence Number: 19823330
• Product Code: FDF
• UDI-Device Identifier: 08714729339359
• UDI-Public: 08714729339359
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2021

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: 06/24/2021
• Device Model Number: M00558420
• Device Catalogue Number: 5842
• Device Lot Number: 0022426962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 71