MAUDE Adverse Event Report: COOK INC CATHETER ACCESS PERCUTANEOUS ENTRY NEEDLE; DRC TROCAR

Model Number	G27257
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Unspecified Mental, Emotional or Behavioural Problem (4430)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.B3: date of event - (b)(6) 2024 e1- postal code: bd20 6td g4: pma/510(k) # - 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.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.
Event or Problem Description
As reported, during a percutaneous nephrolithotomy (pcnl), a catheter access percutaneous entry needle broke while gaining renal access.Attempts were made to retrieve the separated portion of the device; however, the decision was made to leave the remaining sixteen centimeters of the catheter inside the perinephric/subcutaneous space to prevent further harm to the patient.Additional information has been requested.
Event or Problem Description
Additional information was received 22jan2025.Resistance was encountered upon insertion of the catheter, particularly in the renal/perinephric space.The separated fragment was over a wire guide, and the interventional radiologist tried to remove it with vascular catheters, but ¿couldn¿t progress¿.Urologists performed ureteroscopy, but were unable to obtain renal access, as it was sub-urothelial.The stone was removed via a separate puncture and tract.Two ct scans were obtained post-operatively.Per the reporter, the patient has residual stone.A ureteroscopy was performed (b)(6) 2025, as per the standard of care, and the retained fragment was retrieved form the perinephric space at the same time during a laparoscopic procedure, without complication.Reportedly, there have been no physical adverse effects to the patient due to this event.Per the reporter, the patient has reported psychological/mental adverse effects and panic attacks since becoming aware of the event.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: a3, b5, d4, h4, h6 (annex e & f) corrected information: a3, d4.H4, h6 (annex e & f) d4: upon review of additional information received 22jan2025, it was discovered that the lot number was inadvertently omitted from previously submitted reports.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: d9, h3 = information was received 09dec2024 that the device would be returned to cook.The complaint device was returned to cook on 26dec2024 and the device evaluation has begun; however, a conclusion is not yet available.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Summary of event: as reported, during a percutaneous nephrolithotomy (pcnl), a catheter access percutaneous entry needle broke while gaining renal access.Attempts were made to retrieve the separated portion of the device; however, the decision was made to leave the remaining sixteen centimeters of the catheter inside the perinephric/subcutaneous space to prevent further harm to the patient.Additional information was received 22jan2025.Resistance was encountered upon insertion of the catheter, particularly in the renal/perinephric space.The separated fragment was over a wire guide, and the interventional radiologist tried to remove it with vascular catheters, but ¿couldn¿t progress¿.Urologists performed ureteroscopy, but were unable to obtain renal access, as it was sub-urothelial.The stone was removed via a separate puncture and tract.Two ct scans were obtained post-operatively.Per the reporter, the patient has residual stone.A ureteroscopy was performed (b)(6) 2025, as per the standard of care, and the retained fragment was retrieved form the perinephric space at the same time during a laparoscopic procedure, without complication.Reportedly, there have been no physical adverse effects to the patient due to this event.Per the reporter, the patient has reported psychological/mental adverse effects and panic attacks since becoming aware of the event.Investigation evaluation: reviews of the complaint history, device history record (dhr), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted, as well as a supplier investigation.Two used devices were returned to cook for investigation.One device was separated approximately 2.2-centimeters from the hub.The second device showed multiple kinks and impressions along the length of the catheter.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.A supplier investigation was performed.The supplier concluded that all quality standard requirements were met.No deviations or nonconformances were noted.No related quality problems or rejections were found.The supplier concluded that a cause for the separation could not be identified.The supplier did not identify a root cause.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that procedural issues and the patient¿s anatomy contributed to this event.Resistance was encountered upon insertion of the catheter, and vascular catheters ¿couldn¿t progress¿ upon attempted removal of the fragment over the wire guide.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified, and cook will continue to monitor for similar events.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: CATHETER ACCESS PERCUTANEOUS ENTRY NEEDLE
• Common Device Name: DRC TROCAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 20521435
• Report Number: 1820334-2024-01394
• Device Sequence Number: 18324008
• Product Code: DRC
• UDI-Device Identifier: 00827002272576
• UDI-Public: (01)00827002272576(17)260316(10)15281003
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/09/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/16/2026
• Device Model Number: G27257
• Device Catalogue Number: ADN-18-18.0
• Device Lot Number: 15281003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 12/09/2024; 01/22/2025; 04/02/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 01/07/2025; 01/22/2025; 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male