MAUDE Adverse Event Report: COOK INC AMPLATZ ULTRA STIFF PTFE DOUBLE FLEXIBLE WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number N/A

Device Problem Unraveled Material (1664)

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

Event Date 01/23/2024

Event Type  malfunction  

Event Description

It was reported, the amplatz ultra stiff ptfe double flexible wire guide uncoiled during an unspecified procedure.There was no harm to the patient, however it caused inconvenience.No section of the device remained inside the patient's body.There were no adverse effects on the patient due to this occurrence.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Manufacturer Narrative

E1: customer postal code = (b)(6).E3: customer occupation = sr.Clinical risk advisor.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

Additional information received 22feb2024: the procedure was a cystoscopy with ureteral stent exchange.The wire uncoiled when it was being removed from the wire guide after stent placement and was not used through a needle.There was not any resistance when placing the wire guide, but some resistance when it was being removed after the stent placement.The last step to complete the procedure was to remove the wire guide, so another device was not necessary.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.Device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: it was reported, the amplatz ultra stiff ptfe double flexible wire guide uncoiled during a cystoscopy with ureteral stent exchange procedure.The wire uncoiled when it was being removed from the wire guide after stent placement and was not used through a needle.There was not any resistance when placing the wire guide, but some resistance when it was being removed after the stent placement.The last step to complete the procedure was to remove the wire guide, so another device was not necessary.There was no harm to the patient, however it caused inconvenience.No section of the device remained inside the patient's body.There were no adverse effects on the patient due to this occurrence.Investigation ¿ evaluation: a document based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures.A visual inspection of the device was also conducted during the investigation.One amplatz ultra stiff ptfe double flexible wire guide was returned in an open package with the label.Upon inspection the wire guide has become uncoiled.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records found no other complaints reported for the complaint device lot.Based on the available information, cook has concluded that the device was manufactured to specification and there is no evidence suggesting nonconforming product exists either in house or in the field.A review of relevant manufacturing and quality control documents was conducted.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed product labeling; the ifu supplied with the device states the following in consideration of the reported failure mode: "manipulation of wire guide requires appropriate imaging control.Use caution not to force or over manipulate the wire guide when gaining access." "when using wire guide through a metal cannula/needle, use caution as damage may occur to outer coating." based on the available information, cook has concluded a specific cause of the complaint cannot not be established, it was not possible to rule out procedural factors.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: AMPLATZ ULTRA STIFF PTFE DOUBLE FLEXIBLE 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: 18773218
• MDR Text Key: 337072905
• Report Number: 1820334-2024-00263
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AUS-035145-DF
• Device Lot Number: 15700463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 02/22/2024; 05/02/2024
• Supplement Dates FDA Received: 03/13/2024; 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2023
• 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