MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX LOCKING LOOP; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number	M0064101110
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a percutaneous locking loop nephrostomy catheter was placed in the kidney during a percutaneous nephrolithonomy (pcn) procedure performed on (b)(6) 2022.On (b)(6) 2022, it was noticed that the catheter was leaking due to the broken catheter.A tape was temporarily wrapped around the catheter to prevent the leakage.Finally, the catheter was removed, and was replaced with a new catheter on (b)(6) 2022.Note: the photos submitted by the customer shows the catheter was broken in two separate pieces and a kinked on the proximal end of the catheter.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
Block h2: additional information: block b5 (describe event or problem).Block h6: medical device code a0401 captures the reportable event of catheter break.Impact code f23 captures the reportable event of unexpected medical intervention.Block h10: investigation results the returned percutaneous locking loop nephrostomy catheter was analyzed, and a visual evaluation noted that the catheter was with bond around the proximal end.Additionally, the shaft was detached and had the suture entangled.Functional evaluation was performed, and it was found that the mandrel was able to pass through the stent without resistance.Microscopic examination was performed which confirmed the found problems.No other problems with the device were noted.A media analysis was performed to the photos submitted by the customer, and the first photo shows that the catheter was kink at the proximal end.Other photos show the catheter was detached from the shaft.The reported event of catheter break was confirmed.Investigation found that the catheter was kink, this is likely due to the interaction of the device, and handling/manipulation such as an excessive force applied over the device during the procedure, leading to the leakage found on the catheter.Additionally, the breakage reported is considered as part of the procedure.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.Block h11: correction: block b5 (describe event or problem), h6 (impact code) and h10 (additional mfr narrative).
Event or Problem Description
It was reported to boston scientific corporation that a percutaneous locking loop nephrostomy catheter was placed in the kidney during a percutaneous nephrolithonomy (pcn) procedure performed on (b)(6), 2022.On (b)(6), 2022, it was noticed that the catheter was leaking due to the broken catheter.A tape was temporarily wrapped around the catheter to prevent the leakage.On (b)(6) 2022, the catheter was finally removed, and was replaced with another percutaneous locking loop nephrostomy catheter.Note: the photos submitted by the customer show the catheter was broken in two separate pieces and a kinked on the proximal end of the catheter.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 good.Additional information received on december 6, 2022.It was reported that the catheter had to be cut enable to remove from the patient.

• Brand Name: PERCUFLEX LOCKING LOOP
• Common Device Name: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15787649
• Report Number: 3005099803-2022-06504
• Device Sequence Number: 14889844
• Product Code: GBO
• UDI-Device Identifier: 08714729005223
• UDI-Public: 08714729005223
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K820867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2022

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: 11/01/2024
• Device Model Number: M0064101110
• Device Catalogue Number: 410-111
• Device Lot Number: 0028313255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2021
• 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
• Patient Sex: Male