MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00558630
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, it was noted that the balloon could not be inflated.The procedure was completed with another cre pro 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.This event has been deemed reportable based on the investigation results of balloon burst.
Additional Manufacturer Narrative
The patient's exact weight was reported to be 49.5 kg.(b)(4).Investigation results: the returned cre pro wireguided dilatation balloon was analyzed and a visual and microscopic examination found that the balloon was ruptured.No damages were found to the catheter of the device and the guidewire was noted to be bent.With all the available information, boston scientific concludes the reported event was not confirmed.The rupture 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 cause the problem of failure to inflate during the procedure.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.

• Brand Name: CRE PRO
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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: 15136892
• Report Number: 3005099803-2022-04087
• Device Sequence Number: 7372622
• Product Code: FGE
• UDI-Device Identifier: 08714729797517
• UDI-Public: 08714729797517
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112994
• 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
• Report Date (Section B): 07/31/2022

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: 10/13/2021
• Device Model Number: M00558630
• Device Catalogue Number: 5863
• Device Lot Number: 0022935377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 07/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2018
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 50 KG