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

Model Number	M00558480
Medical Device Problem Codes	Burst Container or Vessel (1074); Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: a visual examination of the returned complaint device found the balloon ruptured.No damage was found on the catheter of the device.This failure is likely due to factors or conditions related to procedure, such as handling or manipulation during the preparation, initial set-up or during procedure 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
Note: this report pertains to one of two cre wireguided dilatation balloons used in the same patient and procedure.It was reported to boston scientific corporation that two cre wireguided dilatation balloon were used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon deflated while attempting to be inflated.The same issue occurred with the second cre wireguided dilatation balloon.The procedure was completed another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.Investigation results revealed that the balloon had burst; 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: 10567600
• Report Number: 3005099803-2020-03999
• Device Sequence Number: 16930322
• Product Code: KNQ
• UDI-Device Identifier: 08714729339410
• UDI-Public: 08714729339410
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K110833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2020

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: 10/15/2022
• Device Model Number: M00558480
• Device Catalogue Number: 5848
• Device Lot Number: 0024775606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1