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

Model Number	0010-0612
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a subglottic dilation laryngoscopy procedure, the fiber broke inside the patient.Upon removal of the fiber from the patient body, it was observed that 3.5cm were missing.The operating room staff followed protocol to retain foreign object by performing an x-ray.In addition they re-examined with a glidescope, checked the suction tubing, and canister but the missing fragment was not found.The case was completed by performing temporary tracheostomy.The patient has already been discharged.
Event or Problem Description
It was reported that during a subglottic dilation laryngoscopy procedure, the fiber broke inside the patient.Upon removal of the fiber from the patient body, it was observed that 3.5cm were missing.The operating room staff followed protocol to retain foreign object by performing an x-ray.In addition they re-examined with a glidescope, checked the suction tubing, and canister but the missing fragment was not found.The case was completed by performing temporary tracheostomy.The patient has already been discharged.
Additional Manufacturer Narrative
H6: patient codes were updated.
Additional Manufacturer Narrative
Investigation summary with all the available information, boston scientific concludes that the cause that contributed to the reported fiber tip detachment cannot be established as the product is not available for analysis.Unretrieved device fragments is a known risk associated with subglottic dilation laryngoscopies and is noted as such in the device instructions for use (ifu).Device history record (dhr) the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Labeling review a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.The reported patient effect of unretrieved device fragment is listed in the ifu as potential outcome of this type of procedure.Investigation conclusion based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that during a subglottic dilation laryngoscopy procedure, the fiber broke inside the patient.Upon removal of the fiber from the patient body, it was observed that 3.5cm were missing.The operating room staff followed protocol to retain foreign object by performing an x-ray.In addition they re-examined with a glidescope, checked the suction tubing, and canister but the missing fragment was not found.The case was completed by performing temporary tracheostomy.The patient has already been discharged.

• Brand Name: ENDOSTAT
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 12716320
• Report Number: 2124215-2021-32979
• Device Sequence Number: 16504457
• Product Code: GEX
• UDI-Device Identifier: 00878953000077
• UDI-Public: 00878953000077
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K924644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2021

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: 03/14/2022
• Device Model Number: 0010-0612
• Device Catalogue Number: 0010-0612
• Device Lot Number: 0023487675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 11/01/2021; 11/18/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 11/17/2021; 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown