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

Model Number	M00558390
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2019
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.(b)(4).A visual examination of the complaint device revealed that the balloon and the catheter did not have any visual defects.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to the two pinholes near the middle and distal sections on the body of the balloon.This failure is likely due to factors or conditions related to procedure during the use of the device and/or the presence of sharp objects during the procedure in the dilatation area as the elevator of the scope that was reported as a sharp object by the customer that could have affected its performance and its intended purpose.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 during a dilatation of ampulla procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noticed that the balloon leaked.The procedure was completed at this time.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 the balloon found two pinholes; 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: 8448170
• Report Number: 3005099803-2019-01322
• Device Sequence Number: 3014395
• Product Code: FDF
• UDI-Device Identifier: 08714729339328
• UDI-Public: 08714729339328
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K110833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2019

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: 05/25/2021
• Device Model Number: M00558390
• Device Catalogue Number: 5839
• Device Lot Number: 0022294358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1