MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX NEPHROURETERAL STENT; STENT, URETERAL

Model Number 35095

Device Problems Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2020 as the event date occured two days after being placed inside the patient.The complainant was unable to report the device upn and lot number; therefore, the manufacture date and expiration date are unknown.(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

Note: this report pertains to one of four percuflex locking loop nephrostomy catheters used in the same patient.It was reported to boston scientific corporation that two percuflex locking loop nephrostomy catheters were place into the patient during a procedure performed on (b)(6) 2020.According to the complainant, on (b)(6) 2020, it was noted that both of the catheters were cracked and leaking.Reportedly, the patient had to be transported through medivac for urgent replacement procedure of the catheters two weeks post insertion.Few days after the leakage was noted, a replacement procedure was completed with another two percuflex locking loop nephrostomy catheters; however, the same issue occured with the newly implanted catheters within 2 days inside the patient.Patient is well but scheduled for another tube replacement week of (b)(6).There were no patient complications reported as a result of these events.

Event Description

Note: this report pertains to one of four percuflex locking loop nephrostomy catheters used in the same patient.It was reported to boston scientific corporation that two percuflex locking loop nephrostomy catheters were place into the patient during a procedure performed on (b)(6), 2020.According to the complainant, on (b)(6), 2020, it was noted that both of the catheters were cracked and leaking.Reportedly, the patient had to be transported through medivac for urgent replacement procedure of the catheters two weeks post insertion.Few days after the leakeage was noted, a replacment procedure was completed with another two percuflex locking loop nephrostomy catheters; however, the same issue occured with the newly implanted catheters within 2 days inside the patient.Patient is well but scheduled for another tube replacement week of december 15 to 18.There were no patient complications reported as a result of these events.**additional information received on (b)(6) 2020** reportedly, the devices were used from kidney, through the ureter and into the bladder.

Manufacturer Narrative

Block b3: date of event was approximated to (b)(6) 2020 as the event date occured two days after being placed inside the patient.Block d4, h4: the complainant was unable to report the device upn and lot number; therefore, the manufacture date and expiration date are unknown.Block h6: patient code 3191 captures the reportable event of additional procedure required to replace the defective device.Block h10: 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.Additional information: block b5.

Manufacturer Narrative

Block b3: date of event was approximated to (b)(6) 2020 as the event date occurred two days after being placed inside the patient.Device evaluated by manufacturer: the device was not returned for analysis.Photos from the procedure were provided and reviewed.The images showed the device was implanted in the patient and a shaft kink was visible next to the patient's body.

Event Description

Note: this report pertains to one of four percuflex locking loop nephrostomy catheters used in the same patient.It was reported to boston scientific corporation that two percuflex locking loop nephrostomy catheters were place into the patient during a procedure performed on (b)(6) 2020.According to the complainant, on (b)(6) 2020, it was noted that both of the catheters were cracked and leaking.Reportedly, the patient had to be transported through medivac for urgent replacement procedure of the catheters two weeks post insertion.Few days after the leakeage was noted, a replacment procedure was completed with another two percuflex locking loop nephrostomy catheters; however, the same issue occured with the newly implanted catheters within 2 days inside the patient.Patient is well but scheduled for another tube replacement week of (b)(6).There were no patient complications reported as a result of these events.Reportedly, the devices were used from kidney, through the ureter and into the bladder.It was further reported the replacement procedure occurred on (b)(6) 2020 and non-boston scientific catheters were used.The four boston scientific catheters used prior were percuflex nephroureteral stents.

• Brand Name: PERCUFLEX NEPHROURETERAL STENT
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11002488
• MDR Text Key: 221255092
• Report Number: 3005099803-2020-06078
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K924608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2023
• Device Model Number: 35095
• Device Catalogue Number: 35095
• Device Lot Number: 0025991829
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention