MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; BALLOON DILATOR

Model Number	M00558600
Medical Device Problem Codes	Burst Container or Vessel (1074); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) and endoscopic papillary balloon dilation (epbd) procedure performed on (b)(6) 2021.During preparation, outside the patient, the balloon burst.The procedure was completed with another cre pro wireguided dilatation balloon.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.There were no patient complications reported as a result of this event.

• Brand Name: CRE PRO
• Common Device Name: BALLOON DILATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12334683
• Report Number: 3005099803-2021-04078
• Device Sequence Number: 4980238
• Product Code: FGE
• UDI-Device Identifier: 08714729797487
• UDI-Public: 08714729797487
• Combination Product (Y/N): N
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2021

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: 10/21/2023
• Device Model Number: M00558600
• Device Catalogue Number: 5860
• Device Lot Number: 0026395822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1