MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIGATOR HD; ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY

Model Number	M0062502250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Patient's exact weight: (b)(6).(b)(4).The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath device was used in the right ureter during a cystoscopy, right ureteroscopy with laser lithotripsy and right ureteral stent exchange procedure performed on (b)(6) 2021.During the procedure, a piece of the tip of the sheath broke off and was found floating in the kidney of the patient.Reportedly, the detached piece was retrieved using a disposable stone grasper.The procedure was completed with another navigator hd access sheath device.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.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath device was used in the right ureter during a cystoscopy, right ureteroscopy with laser lithotripsy and right ureteral stent exchange procedure performed on (b)(6) 2021.During the procedure, a piece of the tip of the sheath broke off and was found floating in the kidney of the patient.Reportedly, the detached piece was retrieved using a disposable stone grasper.The procedure was completed with another navigator hd access sheath device.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
Fda registration#: (b)(4).Block a4: patient's exact weight: 81.6 kg.Block h2: additional information: block e1 (initial reporter phone and initial reporter email).Block h6: device code a0401 captures the reportable issue of piece of the sheath's tip broke off inside the patient.Block h10: 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 navigator hd access sheath device was used in the right ureter during a cystoscopy, right ureteroscopy with laser lithotripsy and right ureteral stent exchange procedure performed on (b)(6) 2021.During the procedure, a piece of the tip of the sheath broke off and was found floating in the kidney of the patient.Reportedly, the detached piece was retrieved using a disposable stone grasper.The procedure was completed with another navigator hd access sheath device.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
Fda registration#: (b)(4).Block a4: patient's exact weight: 81.6 kg.Block h6: device code a0401 captures the reportable issue of piece of the sheath's tip broke off inside the patient.Block h10: investigation result: a visual examination of the returned complaint device found that the dilator was cut and was melted at the tip section, thereby the reported event of tip detachment was confirmed.Functional evaluation was performed and the dilator advanced through the sheath without any problem.There were no other problems noted to the device.This failure is likely due to the contact of the dilator with an electrified instrument and/or laser which can cause an overheating of the dilator tip, leading to the tip breaking.Moreover, the dilator tip material was found melted which may be a result of a non-recommended use, handling and manipulation of the device.Therefore, the most probable root cause is unintended use error caused or contributed to event since the interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the instruction for use (ifu)/product label.

• Brand Name: NAVIGATOR HD
• Common Device Name: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11663763
• Report Number: 3005099803-2021-01680
• Device Sequence Number: 16918518
• Product Code: FED
• UDI-Device Identifier: 08714729837992
• UDI-Public: 08714729837992
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140323
• 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,Followup,Followup
• Report Date (Section B): 07/26/2021

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: 10/14/2022
• Device Model Number: M0062502250
• Device Catalogue Number: 250-225
• Device Lot Number: 0026184039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 06/03/2021; 07/08/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 06/25/2021; 07/27/2021
• 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
• Patient Age: 65 YR
• Patient Weight: 82