MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PULMONARY; BRONCHOSCOPE ACCESSORY

Model Number	M00550330
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation catheter was used in the left principal bronchus during a balloon dilatation via fiberoptic bronchoscopy procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon catheter burst while being filled with liquid half way in the left trachea.The procedure was completed with another cre pulmonary dilatation catheter.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter city: (b)(6).Block h6: problem code a0402 captures the reportable event of balloon burst.Block h10: investigation result: a visual examination of the returned complaint device revealed the balloon was torn longitudinally.No damage was found on the catheter of the device.Microscopic inspection confirmed the balloon was torn longitudinally.The reported event of balloon burse was confirmed as the longitudinal tear could have been interpreted by the customer as a burst.It is possible that interaction with the scope or other sharp devices and the use of contrast as inflation medium during procedure could create friction on the balloon, causing leading to the reported issue investigation finding of balloon torn longitudinally during the procedure.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation catheter was used in the left principal bronchus during a balloon dilatation via fiberoptic bronchoscopy procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon catheter burst while being filled with liquid half way in the left trachea.The procedure was completed with another cre pulmonary dilatation catheter.There were no patient complications reported as a result of this event.

• Brand Name: CRE PULMONARY
• Common Device Name: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11874489
• Report Number: 3005099803-2021-02408
• Device Sequence Number: 13705383
• Product Code: KTI
• UDI-Device Identifier: 08714729456216
• UDI-Public: 08714729456216
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K023337
• 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,Followup
• Report Date (Section B): 06/21/2021

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: 08/11/2023
• Device Model Number: M00550330
• Device Catalogue Number: 5033
• Device Lot Number: 0025844709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 49