MAUDE Adverse Event Report: COOK INC PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Catalog Number NTRSE-100038

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Anaphylactic Shock (1703)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, during a percutaneous nephrolithotomy (pcnl) and flexible ureteroscopy using cook devices, the patient suffered from anaphylactic shock due to the chromium within the devices used.The patient had an underlying allergy to chromium.The reaction was treated with corticosteroid treatment, without further implications for the patient.Cook medical devices used during the procedure that contain chromium are: hiwire nitinol core wire guide, amplatz fixed core wire guide, skinny needle with chiba tip, safety wire guide introducer set, ultraxx nephrostomy balloon catheter and set, percutaneous ncircle nitinol tipless stone extractor, ncircle nitinol tipless stone extractor, universa firm ureteral stent set, chiba biopsy needle, dialtor - coons taper.Additional information has been requested.At this time, no other information is known.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

D11: concomitant medical devices- hiwire nitinol core wire guide, amplatz fixed core wire guide, safety wire guide introducer set, ultraxx nephrostomy balloon catheter and set, skinny needle with chiba tip, ncircle nitinol tipless stone extractor, universa firm ureteral stent set, chiba biopsy needle, dialtor - coons taper.G5: pma/510(k) number = exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: section c.Event description: it was reported, during a percutaneous nephrolithotomy (pcnl) and flexible ureteroscopy using multiple cook devices, the patient suffered from anaphylactic shock due to the chromium within the devices used.The patient had an underlying allergy to chromium.The provider reached out to the cook medical area representative prior to the pcnl procedure to inquire about which cook devices commonly used in these procedures contained chromium, however, the provider did not wait for the response before proceeding with the procedure.The reaction was treated with corticosteroid treatment, without further implications for the patient.Investigation ¿ evaluation.A document based investigation was performed including a review of manufacturing instructions, the instructions for use (ifu), and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Cook could not complete a review of the device history record (dhr) or search for other complaints from the product lot due to lack of lot information from the user facility.The instructions for use (ifu), does not supply any information of chromium content in the device.The product specification for the perc ncircle nitinol tipless stone extractor was reviewed, and there were no requirements to provide the material content of the device in the labeling.The provided information stated the patient had a known allergy to chromium and devices that contained chromium were used during the procedure, producing the reported anaphylactic shock.The provider had requested information from cook as to the chromium content of the devices being used, but performed the procedure before the information was received.The conclusion of the investigation is that the cause of the issue was the provider using the devices before the chromium content was known.The chromium content of the device would have made their use contraindicated in this case.The risk analysis for this failure mode was reviewed, and it was determined that no actions are required.Cook will continue monitoring of similar complaints and have notified the appropriate personnel of this event.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR
• Type of Device: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10335679
• MDR Text Key: 201910913
• Report Number: 1820334-2020-01373
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• 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: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NTRSE-100038
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NEPHROSCOPE 22FR STORZ
• Patient Outcome(s): Required Intervention