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

Model Number	M00558640
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(6).(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during an esophageal dilation procedure performed on (b)(6) 2022.During the procedure, the balloon could not be filled while being inflated.The balloon was removed and tested outside the patient.The customer found the balloon was ruptured.Reportedly, the balloon ruptured under 15mm/3atm.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 condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during an esophageal dilation procedure performed on (b)(6) 2022.During the procedure, the balloon could not be filled while being inflated.The balloon was removed and tested outside the patient.The customer found the balloon was ruptured.Reportedly, the balloon ruptured under 15mm/3atm.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 condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block a2: patient exact age is unknown; however, it was reported that the patient was over the age of 18.Block e1: this event was reported by the sales representative.The reported healthcare facility is: (b)(6).Block h6: device code a0402 captures the reportable event of balloon burst.Block h10: investigation result: the returned cre pro wireguided dilatation balloon was analyzed and a visual examination found that the balloon and the catheter of device had no damages.A functional inspection was performed by connecting the device to an alliance inflation system.The balloon inflated without problem, and it was able to maintain its pressure.The reported event of balloon burst was not confirmed.Product analysis determined the device was returned in good condition, with the capability of being inflated and holding pressure.Therefore, the most probable root cause cannot be determined as no problem was detected.

• Brand Name: CRE PRO
• Common Device Name: BALLOON DILATOR
• 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: 15974056
• Report Number: 3005099803-2022-07333
• Device Sequence Number: 12502544
• Product Code: FGE
• UDI-Device Identifier: 08714729797524
• UDI-Public: 08714729797524
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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: 06/24/2025
• Device Model Number: M00558640
• Device Catalogue Number: 5864
• Device Lot Number: 0029827561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• 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: Male