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

Model Number	M00558620
Medical Device Problem Codes	Unsealed Device Packaging (1444); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wire guided dilatation balloon was unpackaged for use in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During preparation outside the patient, it was found that the product package was damaged and it was unknown if sterilization was compromised.The device was not used and 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's condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
This event was reported by the sales representative.The reported healthcare facility and physician is: (b)(6).Imdrf device code a0205 captures the reportable event of packaging damage.
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 is being used to capture the reportable event of packaging seal compromised.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was unpackaged for use in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During preparation outside the patient, it was found that the product package was damaged and it was unknown if sterilization was compromised.The device was not used and 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's condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Correction: no further information has been obtained despite good faith efforts.

• 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 CORPORATION; model farm road; model farm road; cork ; EI
• Manufacturer Contact: carole morley morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16677972
• Report Number: 3005099803-2023-01658
• Device Sequence Number: 17479559
• Product Code: FGE
• UDI-Device Identifier: 08714729797500
• UDI-Public: 08714729797500
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: KS
• 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): 05/16/2023

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: 10/25/2024
• Device Model Number: M00558620
• Device Catalogue Number: 5862
• Device Lot Number: 0028450612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2021
• 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 Sex: Unknown