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

Model Number	M00550310
Medical Device Problem Codes	Use of Device Problem (1670); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
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
Note: this report pertains to one of two cre pulmonary dilatation balloons used in the same patient and procedure.It was reported to boston scientific corporation that two cre pulmonary dilatation balloons were used in the right main stem of the bronchus during a dilation procedure performed on (b)(6) 2021.During the procedure, when attempting to advance the balloon down the working channel and into position the tip kept bending.The balloon was unable to pass into position between the malignancy.The device was removed from the patient and was re-inflated for inspection.The balloon seemed fine until it was passed back down the scope and the tip continued to bend.A second cre pulmonary dilatation balloon was used and the same issue occurred.The procedure was completed with another cre pulmonary dilatation balloon device.Note: the instructions for use (ifu) indicate that the balloon should not be pre-inflated.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: 11919047
• Report Number: 3005099803-2021-02560
• Device Sequence Number: 922140
• Product Code: KTI
• UDI-Device Identifier: 08714729456193
• UDI-Public: 08714729456193
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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: 09/24/2023
• Device Model Number: M00550310
• Device Catalogue Number: 5031
• Device Lot Number: 0026070320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1