MAUDE Adverse Event Report: COOK INC FIXED CORE WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number 635413-10

Device Problem Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.D4 -catalog number: device is not marketed in the united states.There are similar devices marketed in the united states, for example catalog number 635413.Information for 635413: common device name (d2a): ocy endoscopic guidewire, gastroenterology-urology, product code(d2b): ocy, pma/510(k) # (g4): k082536.E1: customer name and address = postal code: (b)(6).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

As reported, the fixed core wire guide "split" during the procedure.The procedure was successfully complete with another same-like device.The patient had no adverse effects reported.Additional information has been requested but is unavailable at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Event description: as reported, a fixed core wire guide "split" during a percutaneous replacement of an unspecified multi-length ureteral stent.The split in the wire guide was discovered at the end of the procedure, when the ureteral stent was half way through the ureter and would not advance any further.They were unable to remove the ureteral stent.The wire guide and the ureteral stent were removed at the same time.A new wire guide was placed and a new ureteral stent was used to complete the procedure.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.Investigation - evaluation reviews of complaint history, device history record (dhr), and quality control procedures were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.A photo was provided which shows the wire guide had become unraveled at one end.The complete wire guide is not visible in the photo.A document based investigation evaluation was performed.The available evidence indicates the device was manufactured to specification.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other related complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.A review of manufacturing procedures found controls to be in place to assure device integrity prior to shipping.Based on the available information, a definitive cause could not be determined.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor for similar complaints.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 Description

Additional information was received 18oct2023 and 14nov2023: as reported, a fixed core wire guide "split" during a percutaneous replacement of an unspecified multi-length ureteral stent.The split in the wire guide was discovered at the end of the procedure, when the ureteral stent was half way through the ureter and would not advance any further.They were unable to remove the ureteral stent.The wire guide and the ureteral stent were removed at the same time.A new wire guide was placed and a new ureteral stent was used to complete the procedure.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Correction: d9, h3, h6 type of investigation (annex b) additional information: h10 event description: as reported, a fixed core wire guide "split" during a percutaneous replacement of an unspecified multi-length ureteral stent.The split in the wire guide was discovered at the end of the procedure, when the ureteral stent was half way through the ureter and would not advance any further.They were unable to remove the ureteral stent.The wire guide and the ureteral stent were removed at the same time.A new wire guide was placed and a new ureteral stent was used to complete the procedure.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.Investigation ¿ evaluation a visual inspection of the returned device was conducted.One fixed core wire guide was returned for investigation.The wire guide was visually inspected and the wire guide has the inner core exposed.There are also kinks and bends along the length of wire guide.Cook has concluded based on the available information a specific cause of the complaint could not be established.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, no further action is required.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

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

• Brand Name: FIXED CORE WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• 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: 17886676
• MDR Text Key: 325115253
• Report Number: 1820334-2023-01349
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002341340
• UDI-Public: (01)00827002341340(17)251212(10)15118906
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 635413-10
• Device Lot Number: 15118906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1