MAUDE Adverse Event Report: COOK INC COPE NITINOL MANDRIL WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number N/A

Device Problem Unraveled Material (1664)

Patient Problem Hematoma (1884)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: preamendment.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 an unknown patient required a cope nitinol mandril wire guide for a picc line placement procedure.The operator punctured the basilic vein with a 21 gage vascular needle and inserted the wire guide into the needle.The wire guide was difficult to advance and the operator manipulated and pulled the wire.The wire guide frayed within the puncture needle.The patient had a hematoma and the vein was damaged as a result.The procedure was successfully completed with another wire guide.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation.(b)(6) , in france, informed cook of an incident involving a cope nitinol mandril wire guide.The complainant reported that after puncturing the basilic vein with a 21g needle, the wire guide was inserted through the needle.The wire was difficult to advance and when withdrawn, it frayed in the needle during a picc line placement.Further communication with the user facility clarified that the wire was withdrawn because it would not advance, the wire was manipulated while inserted through the needle.The patient developed a hematoma, as the vein was damaged, and another vein had to be punctured.A review of the complaint history, device history record, instructions for use (ifu), quality control of the device, as well as a visual inspection, were conducted during the investigation.The complainant returned a cope nitinol mandril wire guide to cook for investigation.The physical/visual examination of the returned device showed: one used and damaged wire guide was returned.The wire guide is unraveled starting at the soldered junction.The weld ball is missing, and the safety/mandril wire is protruding out.Additionally, a document-based investigation evaluation was performed.The risks associated with these devices are acceptable when weighed against the benefits.Sufficient inspection activities are in place to identify this failure mode prior to distribution.There is no instructions for use (ifu) supplied wit the cope mandril wire guide.However, there is a label attached to the wire guide holder/hoop with an image warning the user not to remove the wire guide through the needle.The device history record (dhr) was reviewed.The dhr for the lot recorded a related nonconformance.One device was scrapped for offset coil.The device is 100% inspected for offset coils.Cook also completed dhr reviews for sub-assemblies and components, and no non-conformances were recorded.A complaints database search was conducted which revealed no additional complaints for the lot from the field.As 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 field.A label is attached to the wire guide holder with an image warning not to remove the wire through the needle.The user removed the wire through the needle and manipulated the wire while in the needle, which likely caused the needle to get caught on the tip of the needle and contributed to the unravelling.Based on the information provided, inspection of returned product and the results of the investigation, cook has concluded that the main cause of the failure is due to unintended user error.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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 Description

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

• Brand Name: COPE NITINOL MANDRIL WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10987950
• MDR Text Key: 223781106
• Report Number: 1820334-2020-02278
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00827002084278
• UDI-Public: (01)00827002084278(17)240805(10)9877111
• 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: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• 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: PMG-18SP-60-COPE-NT
• Device Lot Number: 9877111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN MANUFACTURER 21 GAGE VASCULAR NEEDLE