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

Model Number	M00558680
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a020504 captures the reportable event of a hole in the device packaging.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was received by the customer on an unknown date.It was reported that upon receiving the packaging, the balloon packaging was perforated/torn in the areas where the scratches are observed.Media inspection of the product packaging provided by the complainant revealed multiple small punctures and indentations located on the sterile pouch.The damage appears as several clustered pin sized penetrations and surface dents on the front side of the sterile pouch.The complainant also reported that the outer shipping box containing the sterile balloon pouches showed no signs of damage.The device was not used in a procedure.No patient was involved at the time of event, and no patient complications were reported in connection with this event.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24598977
• Report Number: 3005099803-2026-00962
• Device Sequence Number: 9434245
• Product Code: FGE
• UDI-Device Identifier: 08714729797562
• UDI-Public: (01)08714729797562(17)281211(10)38176726
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2026

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 Model Number: M00558680
• Device Catalogue Number: M00558680
• Device Lot Number: 0038176726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 04/09/2026; 05/21/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/01/2026; 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2025
• 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