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

Model Number	M00558420
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the esophagus during an esophageal stent implantation procedure performed on (b)(6) 2021.During the procedure, the balloon burst during inflation.The procedure was completed with another cre wireguided dilation balloon.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the esophagus during an esophageal stent implantation procedure performed on (b)(6) 2021.During the procedure, the balloon burst during inflation.The procedure was completed with another cre wireguided dilation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(6).Block h6: device code a0402 captures the reportable event of balloon burst.Block h10: investigation results.A visual examination of the returned complaint device found that the balloon was torn longitudinally, which confirms the reported event of balloon burst.No damage found on the catheter of the device.Based on the available information, it is possible that factors encountered during the procedure, the interaction with scope or any other surface during the procedure could create friction on the balloon and caused the balloon to tear longitudinally.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.

• 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: 12568792
• Report Number: 3005099803-2021-05111
• Device Sequence Number: 4053604
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

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: 07/13/2023
• Device Model Number: M00558420
• Device Catalogue Number: 5842
• Device Lot Number: 0025849191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 78