MAUDE Adverse Event Report: COOK INC AMPLATZ STIFF SUPPORT WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G27032
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name & product code = dqx wire, guide, catheter.(b)(6).Occupation: charge tech.Pma/510(k) number: pre-amendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a tunnel line procedure, an amplatz stiff support wire guide "shredded" upon removal from a cook catheter.The wire became stuck in the catheter; therefore, the physician cut the catheter and the wire and catheter were removed together.After removal from the patient, the physician attempted to remove the wire from the catheter; however, the wire "shredded" upon attempted removal.Additional information has been requested, but is unavailable at this time.
Event or Problem Description
Additional information was received 14jul2020 and 23jul2020.The complaint device was inserted in order to exchange the cook catheter for serial tract dilation during tunneled line insertion.Initial access was obtained in the right internal jugular vein with an unknown j-wire and the cook catheter was advanced to the inferior vena cava.No tortuosity or other abnormalities were noted.When the wire guide became stuck on the catheter, the user cut the catheter in order to place a sheath over the device to maintain access.The wire and catheter were then removed from the patient.As the user attempted to remove the wire from the catheter, outside of the patient, the wire began to unravel and come apart.Another catheter and wire were used to complete the procedure.The patient was reportedly "fine".
Additional Manufacturer Narrative
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
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a tunnel line procedure, an amplatz stiff support wire guide "shredded" upon removal from a cook catheter.The wire became stuck in the catheter; therefore, the physician cut the catheter and the wire and catheter were removed together.After removal from the patient, the physician attempted to remove the wire from the catheter; however, the wire "shredded" upon attempted removal.Additional information was received 14jul2020 and 23jul2020.The complaint device was inserted in order to exchange the cook catheter for serial tract dilation during tunneled line insertion.Initial access was obtained in the right internal jugular vein with an unknown j-wire and the cook catheter was advanced to the inferior vena cava.No tortuosity or other abnormalities were noted.When the wire guide became stuck on the catheter, the user cut the catheter in order to place a sheath over the device to maintain access.The wire and catheter were then removed from the patient.As the user attempted to remove the wire from the catheter, outside of the patient, the wire began to unravel and come apart.Another catheter and wire were used to complete the procedure.The patient was reportedly "fine".Investigation evaluation: reviews of the complaint history, device history record, manufacturing instructions, and quality control procedures were conducted during the investigation.A visual examination of the complaint device was also conducted.The complaint device was returned, stuck inside the kmp catheter.Approximately 26.1 centimeters of elongated wire coil exited the proximal end of the catheter.The wire was kinked in two locations.During attempts to remove the complaint device from the catheter, the wire separated at 10 centimeters from the bond site.The catheter was cut with scissors and the wire was removed.Tissue was found on the wire guide.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.There is objective evidence to support that the device was manufactured to specification.Cook also reviewed the device master record including: drawings, manufacturing instructions, quality controls, material specifications and design history file.It was concluded that there are adequate controls in place to mitigate the risk of this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a definitive cause for the event cannot be determined; although, there is no evidence to suggest manufacturing issues were at fault.Possible causes for this failure include procedural issues or patient anatomy.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.

• Brand Name: AMPLATZ STIFF SUPPORT WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10233071
• Report Number: 1820334-2020-01253
• Device Sequence Number: 13581854
• Product Code: DQX
• UDI-Device Identifier: 00827002270329
• UDI-Public: (01)00827002270329(17)250424(10)13112823
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2025
• Device Model Number: G27032
• Device Catalogue Number: THSF-35-145-ASG
• Device Lot Number: 13112823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 07/14/2020; 10/08/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 07/24/2020; 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK HNBR5.0-38-40-P-NS-KMP