MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIVA ID; POWERED LASER SURGICAL INSTRUMENT

Model Number	M006R8403930
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was reported to the fda via a voluntary medwatch report.(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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on january 7, 2019 that a flexiva id 550 laser fiber was used during a rigid bronchoscopy, laser ablation, mechanical debulking, electrocautery snare, balloon dilation, stent placement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the laser fiber was placed in the bronchoscope channel with tip remaining intact.The channel was removed as planned.After re-introducing the fiber it was noted that the tip was fractured.The tip was found buried in the airway mucosa later on and was retrieved without incident.The procedure was completed with a second flexiva id 550 laser fiber there were no patient complications reported as a result of this event.

• Brand Name: FLEXIVA ID
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8281700
• Report Number: 3005099803-2019-00296
• Device Sequence Number: 1952854
• Product Code: GEX
• UDI-Device Identifier: 08714729963790
• UDI-Public: 08714729963790
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K100078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2021
• Device Model Number: M006R8403930
• Device Catalogue Number: 69269
• Device Lot Number: 0000006548
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 01/28/2019
• 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: Required Intervention