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

Model Number M00558620

Device Problems Unsealed Device Packaging (1444); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2023

Event Type  malfunction  

Event 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.

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.

Manufacturer Narrative

Block h6: imdrf device code a020503 is being used to capture the reportable event of packaging seal compromised.

Event 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
• Type of Device: 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
• MDR Text Key: 312752057
• Report Number: 3005099803-2023-01658
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729797500
• UDI-Public: 08714729797500
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K112994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1