MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIGATOR; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M0062502020
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medwatch number is mw5103237.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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 that a navigator access sheath was used in the bladder during a procedure performed on (b)(6) 2021.During the procedure, when the flexible ureteroscope and sheath were removed it was noticed that there were plastic coating from multiple areas of the sheath that disintegrated.It was reported that there was no evidence of damage to any other devices used in the procedure.The cystoscope was re-introduced into the bladder and multiple fragments were irrigated out.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block g2: medwatch number is mw5103237.Block h2: additional information: block b5 (describe event or problem), block d7 (sud reprocessed/reused) and h8 (usage of device).Block h6: device problem code a040506 captures the reportable event sheath peeled.Evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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 access sheath was used in the bladder during a procedure performed on (b)(6) 2021.During the procedure, when the flexible ureteroscope and sheath were removed it was noticed that there were plastic coating from multiple areas of the sheath that disintegrated.It was reported that there was no evidence of damage to any other devices used in the procedure.The cystoscope was re-introduced into the bladder and multiple fragments were irrigated out.There were no patient complications reported as a result of this event.Additional information received on september 28, 2021.It was reported that cystourethroscopy, laser lithotripsy procedure was performed and was completed with this device.

• Brand Name: NAVIGATOR
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12525433
• Report Number: 3005099803-2021-05010
• Device Sequence Number: 4584433
• Product Code: KOD
• UDI-Device Identifier: 08714729429944
• UDI-Public: 08714729429944
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K030956
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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: 01/21/2022
• Device Model Number: M0062502020
• Device Catalogue Number: 250-202
• Device Lot Number: 0025084346
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 10/20/2021
• 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: Other