MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK CRE¿ PULMONARY; BRONCHOSCOPE ACCESSORY

Model Number	M00550320
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 balloon was used in the trachea during a balloon dilation procedure on (b)(6) 2017.According to the complainant, during the procedure, the balloon could not be deflated and had to be cut in half to be pulled out manually in the patient's airway using the forceps.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Investigation results: a visual examination of the complaint device revealed that the balloon was cut in the middle, which is consistent with the customer¿s statement that the balloon was manually cut in order to be removed from the scope/patient.Functional analysis could not be performed due to the condition of the device.The noted defect likely occurred due to anatomical/procedural factors encountered during the procedure that could have limited the performance of the balloon.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.There was no evidence to suggest that the device was used in a manner inconsistent with the labeled indications.A search of the complaint database revealed that no other complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the trachea during a balloon dilation procedure on (b)(6) 2017.According to the complainant, during the procedure, the balloon could not be deflated and had to be cut in half to be pulled out manually in the patient's airway using the forceps.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's 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 - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 6694624
• Report Number: 3005099803-2017-01904
• Device Sequence Number: 19025509
• Product Code: KTI
• UDI-Device Identifier: 08714729456209
• UDI-Public: (01)08714729456209(17)20190131(10)0020244999
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: M00550320
• Device Catalogue Number: 5032
• Device Lot Number: 0020244999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention