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

Model Number M0062502250

Device Problems Difficult to Insert (1316); Material Integrity Problem (2978)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a navigator hd access sheath was used in the right ureter during a flexible ureteroscopy (furs) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that the access sheath was difficult to advance through the ureter which caused minor injury to the patient.In the physician assessment, the minor injury was caused by the unevenness of the device hydrophilic coating.The procedure was completed with another navigator hd access sheath.Reportedly, the patient was given medication to treat the minor injury and was required to stay longer in the hospital.The patient was under observation following the treatment.

Manufacturer Narrative

Block e1: initial reporter facility name: (b)(6).Block h6: patient code 2104 captures the reportable event of patient tissue damage.Block h10: investigation results: a visual examination of the returned complaint device found that both the sheath and the dilator were bent.It was also noted that the coating was visibly uneven in some areas of the sheath.Additionally, there are residues observed on the dilator which indicates use and handling of the device.Functional analysis was performed, the sheath and dilator surfaces were moistened with water and they became slippery, indicating coating was applied on both devices.This failure is likely due to anatomical factors encountered during the procedure, such as the interaction between the sheath and with the other devices, and handling of the device during the procedure, could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.The reported issue of "tissue damage" could not be functionally/visually verified, therefore it was not confirmed, however the directions for use indicates the potential adverse events associated with the use of the transurethral access device and it mentions "tissue damage", there the reported event of "tissue damage" will be documented as "known inherent risk of device" since the reported adverse event known and documented in the labeling (including both short or long term known complications or adverse reactions).A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a navigator hd access sheath was used in the right ureter during a flexible ureteroscopy (furs) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that the access sheath was difficult to advance through the ureter which caused minor injury to the patient.In the physician assessment, the minor injury was caused by the uneveness of the device hydrophilic coating.The procedure was completed with another navigator hd access sheath.Reportedly, the patient was given medication to treat the minor injury and was required to stay longer in the hospital.The patient was under observation following the treatment.The minor injury the patient experienced is abrasion of the ureter.Reportedly, the patient's condition has improved following the treatment, and the patient was then discharged from the hospital.

• Brand Name: NAVIGATOR HD
• Type of Device: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9947759
• MDR Text Key: 187176485
• Report Number: 3005099803-2020-01606
• Device Sequence Number: 1
• Product Code: FED
• UDI-Device Identifier: 08714729837992
• UDI-Public: 08714729837992
• Combination Product (y/n): N
• PMA/PMN Number: K140323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2021
• Device Model Number: M0062502250
• Device Catalogue Number: 250-225
• Device Lot Number: 0024384454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR