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

Model Number 35095

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to report the device upn and lot number; therefore, the manufacture date and expiration date are unknown.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, 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 december 15 to 18.There were no patient complications reported as a result of these events.

Manufacturer Narrative

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: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, 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 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 22dec2020.Reportedly, the devices were used from kidney, through the ureter and into the bladder.

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: 10994782
• MDR Text Key: 221235250
• Report Number: 3005099803-2020-06049
• 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

• 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
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/12/2020
• Supplement Dates Manufacturer Received: 12/22/2020; 01/18/2021
• Supplement Dates FDA Received: 01/13/2021; 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention