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

Model Number	M00550300
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary balloon was used in the left main stem bronchus during a bronch dilation and stent placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that the balloon popped, and the patient experienced bleeding.The bleeding corrected itself via natural coagulation.No additional dilation was needed at this point.An ultraflex airway stent was then successfully placed, and the procedure was completed at this time.In the physicians assessment, the balloon popping aggravated the patients airway, causing the bleeding.It was reported that the patient condition at the conclusion of the procedure was reported to be stable.

• 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: 10667279
• Report Number: 3005099803-2020-04456
• Device Sequence Number: 3960308
• Product Code: KTI
• UDI-Device Identifier: 08714729456186
• UDI-Public: 08714729456186
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K023337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2020

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: 01/12/2023
• Device Model Number: M00550300
• Device Catalogue Number: 5030
• Device Lot Number: 0025029890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 84