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

Model Number	M00550340
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The device has not been received for analysis.Upon receipt and 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 balloon was used in the bronchus during an endoscopic pulmonary dilatation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the patient started to bleed during the first dilation.The balloon was removed in order to perform bleeding management in the form of energy coagulation.The balloon was introduced again but was unable to pass through the working channel of the scope, and it was observed that the distal tip of the catheter was bent.The procedure was completed with another cre pulmonary dilatation balloon device.Per the physician assessment, the bleeding was due to the vascular tissue, not due to the balloon.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 pulmonary dilatation balloon was used in the bronchus during an endoscopic pulmonary dilatation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the patient started to bleed during the first dilation.The balloon was removed in order to perform bleeding management in the form of energy coagulation.The balloon was introduced again but was unable to pass through the working channel of the scope, and it was observed that the distal tip of the catheter was bent.The procedure was completed with another cre pulmonary dilatation balloon device.Per the physician assessment, the bleeding was due to the vascular tissue, not due to the balloon.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: problem code 2981 captures the reportable issue of tip bent.Block h10: investigation results: visual examination of the returned complaint device found the tip of the balloon had no anomalies noted.No damage was found on the catheter of the device.The reported failure is likely due to factors encountered during the procedure, such as handling of the device, the technique used by the physician, the interaction with the scope, and/or the interaction with the scope.Bleeding is a known adverse event of the device as stated in the dfu and could have been caused by tip deviation as a result of the balloon having difficulty passing through the working channel, as stated in the reported event.Therefore, the most probable root cause is known inherent risk of device.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.

• 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: 9683143
• Report Number: 3005099803-2020-00213
• Device Sequence Number: 3414215
• Product Code: KTI
• UDI-Device Identifier: 08714729456223
• UDI-Public: 08714729456223
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K023337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

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: 06/05/2022
• Device Model Number: M00550340
• Device Catalogue Number: 5034
• Device Lot Number: 0023909079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1