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

Model Number	M00558630
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code (b)(4) captures the reportable event of balloon leaked in the esophagus.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the proximal esophagus during an esophageal dilatation procedure on (b)(6) 2022.During the procedure, a leak was discovered at the distal tip of the balloon and it could not be fully inflated.The procedure was completed with the original device at this time.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 pro wireguided dilatation balloon was used in the proximal esophagus during an esophageal dilatation procedure on (b)(6) 2022.During the procedure, a leak was discovered at the distal tip of the balloon and it could not be fully inflated.The procedure was completed with the original device at this time.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a0504 captures the reportable event of balloon leaked in the esophagus.Block h10: investigation results block h10: investigation results the returned cre pro wireguided dilatation balloon was analyzed and a visual examination found that the balloon and catheter of the device had no damages.Functional analysis was performed and the balloon was inflated without a problem.However, the balloon would not hold pressure due to a pinhole in the balloon.Microscopic inspection found the balloon had a pinhole located approximately 18mm from the tip.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of balloon leak was confirmed.The pinhole found in the balloon is likely to have occurred due to factors encountered during the procedure: excess pressure, interaction with other devices, anatomical restrictions or interaction with any surface during the procedure could create friction on the balloon and cause a pinhole.Therefore, the most probable root cause is adverse event related to procedure.

• 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: 15718930
• Report Number: 3005099803-2022-06340
• Device Sequence Number: 7542178
• Product Code: FGE
• UDI-Device Identifier: 08714729797517
• UDI-Public: 08714729797517
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2022

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: 01/31/2025
• Device Model Number: M00558630
• Device Catalogue Number: 5863
• Device Lot Number: 0028975806
• 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: 10/13/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2022
• 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 Sex: Unknown