MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX PLUS; CATHETER, BILIARY, DIAGNOSTIC

Model Number M0061752530

Device Problems Material Integrity Problem (2978); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a010402 captures the reportable event of stent migration.

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a retrograde intrarenal surgery in the kidney, performed on (b)(6) 2023.During the procedure, the stent was unable to be inserted as the catheter's tip was not properly bent.It was noted that the stent would not place and when trying to finish the placement, the stent would go down by itself from the kidney.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 Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a retrograde intrarenal surgery in the kidney, performed on (b)(6) 2023.During the procedure, the stent was unable to be inserted as the catheter's tip was not properly bent.It was noted that the stent would not place and when trying to finish the placement, the stent would go down by itself from the kidney.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.

Manufacturer Narrative

Block h6: imdrf device code a010402 captures the reportable event of stent migration.Block h11: correction to block h10 pi analysis has been updated.The returned percuflex plus ureteral stent were analyzed, and a visual evaluation noted that there was no problem found in the device.It was noted that the suture was not returned, however the positioner was returned.A mandrel 0.039 was loaded into the device and no resistance was felt.During the microscopic inspection, there was no problem found.No other problems with the device were noted.Taking all available information into consideration, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.Since the reported event the stent migration, is known and documented in the labeling, therefore, the cause code for this will be known inherent risk of device.The investigation assigned the most probable conclusion code of no problem detected.This conclusion was selected since it was reported coil memory however, after inspections of the complaint device, it was not possible to identify any evidence of either the alleged problem or any defect on the device.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.

Manufacturer Narrative

Block h6: imdrf device code a010402 captures the reportable event of stent migration.Block h10: the returned percuflex plus ureteral stent were analyzed, and a visual evaluation noted that there was no problem found in the device.It was noted that the suture was not returned, however the positioner was returned.A mandrel 0.039 was loaded into the device and no resistance was felt.No other problems with the device were noted.Taking all available information into consideration, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.Since the reported event the stent migration, is known and documented in the labeling, therefore, the cause code for this will be known inherent risk of device.The investigation assigned the most probable conclusion code of no problem detected.This conclusion was selected since it was reported coil memory however, after inspections of the complaint device, it was not possible to identify any evidence of either the alleged problem or any defect on the device.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a retrograde intrarenal surgery in the kidney, performed on (b)(6) 2023.During the procedure, the stent was unable to be inserted as the catheter's tip was not properly bent.It was noted that the stent would not place and when trying to finish the placement, the stent would go down by itself from the kidney.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.

• Brand Name: PERCUFLEX PLUS
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17262822
• MDR Text Key: 318553145
• Report Number: 3005099803-2023-03533
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729056812
• UDI-Public: 08714729056812
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2023

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
• Device Operator: Health Professional
• Device Model Number: M0061752530
• Device Catalogue Number: 175-253
• Device Lot Number: 0029007974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 08/07/2023; 08/07/2023
• Supplement Dates FDA Received: 08/29/2023; 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention