MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACQUIRE PULMONARY; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	M00552400
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to provide the suspect device upn and lot number; therefore, the expiration date, device manufacture dates are unknown.Premarket/510(k) #: k163248 & k151895.(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 an acquire pulmonary needle was used during an endobronchial ultrasound bronchoscopy (ebus) procedure performed on an unknown date.According to the complainant, during procedure, the needle coiled too much which resulted in the needle poking the mediastinum and causing a pneumothorax.It is unknown how this procedure was completed.Despite the report of prolonged hospitalization, the patient's condition at the conclusion of the procedure was reported to be fine.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: ACQUIRE PULMONARY
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9340512
• Report Number: 3005099803-2019-05570
• Device Sequence Number: 2734636
• Product Code: EOQ
• UDI-Device Identifier: 08714729986249
• UDI-Public: 08714729986249
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 11/19/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00552400
• Device Catalogue Number: 5240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/19/2019
• 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: Hospitalization