MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE WIREGUIDED; DILATOR, ESOPHAGEAL

Model Number	M00558440
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block g2: user facility reference number: (b)(4).Block h6: imdrf code a0402 captures the reportable event of balloon burst.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the larynx during a direct laryngoscopy procedure performed on (b)(6) 2023.During the procedure, the balloon ruptured.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the larynx during a direct laryngoscopy procedure performed on (b)(6) 2023.During the procedure, the balloon ruptured.No further information has been obtained despite good faith efforts.***additional information was received on may 30, 2023*** the device was used in the trachea (2cm below the vocal cords/glottis) during a direct laryngoscopy with rigid bronchoscopy and co2 laser resection of subglottic stenosis with balloon dilation.It was reported that the balloon ruptured at 20mm inside the patient but remained as one piece.No extra pieces were found after the physician exam.The procedure was completed with another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block a4: weight: 84.9 kg block g2: user facility reference number: mw5116845 block h2: additional information: e1 (initial reporter address 1, initial reporter city) and initial reporter zip/post code) have been updated based on the additional information received on june 21, 2023.Block h6: imdrf code a0402 captures the reportable event of balloon burst.
Additional Manufacturer Narrative
Block a4: weight: 84.9 kg block g2: user facility reference number: mw5116845 block h6: imdrf code a0402 captures the reportable event of balloon burst.Block h2: additional information: blocks a1(patient identifier), a2 (date of birth), a3 (sex), a5 (ethnicity), block a6 (race), e1 (initial reporter title, initial reporter first name, initial reporter last name and initial reporter email), e3 (occupation), h6 (impact codes) and h10 (additional mfr narrative) have been updated based on the additional information received on may 30, 2022.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the larynx during a direct laryngoscopy procedure performed on (b)(6) 2023.During the procedure, the balloon ruptured.No further information has been obtained despite good faith efforts.***additional information was received on may 30, 2023*** the device was used in the trachea (2cm below the vocal cords/glottis) during a direct laryngoscopy with rigid bronchoscopy and co2 laser resection of subglottic stenosis with balloon dilation.It was reported that the balloon ruptured at 20mm inside the patient but remained as one piece.No extra pieces were found after the physician exam.The procedure was completed with another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.

• Brand Name: CRE WIREGUIDED
• Common Device Name: DILATOR, ESOPHAGEAL
• 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: 16955622
• Report Number: 3005099803-2023-02641
• Device Sequence Number: 6850394
• Product Code: FDT
• UDI-Device Identifier: 08714729339373
• UDI-Public: 08714729339373
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K110833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2023

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: 10/29/2025
• Device Model Number: M00558440
• Device Catalogue Number: 5844
• Device Lot Number: 0030620120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 05/30/2023; 06/21/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 06/21/2023; 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White