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Model Number 35095 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problems
No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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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.
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Event Description
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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 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.Reportedly, the devices were used from kidney, through the ureter and into the bladder.
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Manufacturer Narrative
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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.
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Event Description
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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 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.Reportedly, the devices were used from kidney, through the ureter and into the bladder.It was further reported the replacement procedure occurred on december 15, 2020 and non-boston scientific catheters were used.The four boston scientific catheters used prior were percuflex nephroureteral stents.
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Search Alerts/Recalls
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