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

Model Number	M00558400
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the papilla of duodenum during a biliary tract dilation procedure performed on (b)(6) 2022.During the procedure, the balloon burst and leaked water.The procedure was completed with another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Block h6: problem code a0402 captures the reportable event of balloon burst.Block h10: investigation results: the returned cre wireguided dilatation balloon was analyzed and a visual examination found no damages to the catheter or balloon of the device.A functional inspection was performed by connecting the device to an alliance inflation system.The balloon inflated without problem, however, it did not hold pressure due to three pinholes located in the middle section.The balloon burst was not confirmed.With all the available information, boston scientific concludes the three pinholes found in the balloon is likely to have occurred due to factors encountered during the procedure; excess pressure, interaction with other devices, or anatomical affairs.It is possible that factors encountered during the procedure, such as the interaction with any surface, could create friction on the balloon and causing the pinholes.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.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 papilla of duodenum during a biliary tract dilation procedure performed on (b)(6) 2022.During the procedure, the balloon burst and leaked water.The procedure was completed with another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.

• Brand Name: CRE WIREGUIDED
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15265650
• Report Number: 3005099803-2022-04706
• Device Sequence Number: 17589179
• Product Code: FDF
• UDI-Device Identifier: 08714729339335
• UDI-Public: 08714729339335
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2022

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: 07/31/2024
• Device Model Number: M00558400
• Device Catalogue Number: 5840
• Device Lot Number: 0027940757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 60 KG