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

Model Number M00550330

Device Problem Burst Container or Vessel (1074)

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

Event Date 03/25/2021

Event Type  malfunction  

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 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.

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 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
• Type of Device: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11874489
• MDR Text Key: 253811447
• Report Number: 3005099803-2021-02408
• Device Sequence Number: 1
• Product Code: KTI
• UDI-Device Identifier: 08714729456216
• UDI-Public: 08714729456216
• Combination Product (y/n): N
• PMA/PMN Number: K023337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 49