MAUDE Adverse Event Report: COOK INC COOK SPECTRUM; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Difficult to Remove (1528); Unraveled Material (1664); Deformation Due to Compressive Stress (2889)

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

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

Brand name: cook spectrum minocycline/rifampin impregnated double lumen central venous catheter customer person: phone: (b)(6).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 a patient required a cook spectrum minocycline/rifampin impregnated double lumen central venous catheter.After the catheter was placed in the patient's subclavian vein, the user experienced difficulty removing the wire guide from the catheter.As a result, the user removed the device in its entirety and completed the procedure with a like device.A photo provided by the customer depicts unraveling of the wire guide.It was noted that the wire guide was never removed through a needle.No kinking or bending of the wire guide was noted during the procedure.No difficulty advancing the wire guide was experienced.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Correction: med device problem.Investigation ¿ evaluation.(b)(6) hospital informed cook of an event involving a c-udlm-801j-abrm-hc (cook spectrum minocycline/rifampin impregnated double lumen central venous catheter) from lot 13612165.It was reported that after the cvc catheter placement, the doctor met difficulty when he withdraw the guide wire from patient.Based on the patient safety concern, he finally withdraw entire device and guide wire for replaced a new set of cvc.No adverse effects reported to patient.A review of the complaint history, device history record, instructions for use (ifu), and quality control procedures, as well as a visual inspection of the returned product, were conducted during the investigation.One used catheter and wire guide were received.A kink was located approximately 5 cm from the distal tip apex of the curve.Elongation stretches from 6 cm beyond the kink.Another elongated section was noted 28 cm from the curve, measuring 11 cm.A third area of elongation was 44 cm from the curve and measures 16 cm.The full length of the device is 90 cm measuring from the apex of the curve to the proximal end.Additionally, a document based investigation evaluation was performed.A review of the device master record (dmr) determined there are controls in place to address the reported failure mode.A review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr for the complaint lot found no relevant nonconformances.The relevant hdoc-32-60-0-2.5-hts-mwg wire guide component lot did not have abnormalities upon incoming quality control.A database search for complaints on the reported lot found one additional complaint reported from the field, however this complaint was reported by the same facility for a similar incident involving the same patient.It was concluded that no nonconforming product from this lot exists in house or in the field.Cook has documentation in place to address the potential failure of "device not clean or has dents, scratches, or kinks." there are controls in place for this failure.The current instructions for use [c_t_udlm_rev2] state the following: "instructions for use: 8.Introduce the central venous catheter over wire guide.While maintaining the wire guide position, advance catheter into vessel with a gentle twisting motion.Note: do not advance the catheter tip beyond distal tip of wire guide.Always have wire guide leading during catheter placement.Verify catheter tip position using radiography or appropriate technology.9.After catheter is in position, remove wire guide.Note: a wire guide that is at least twice as long as the catheter is recommended for catheter exchange procedure.How supplied: upon removal from package, inspect the product to ensure no damage has occurred." the information provided upon review of the dmr, dhr, dfa and the design history file do not provide evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house are nonconforming.Cook confirmed that the guide wire was kinked and stretched, and that may have led to difficulty operating this device.Cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.The appropriate internal personnel have been notified.Per the 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.

• Brand Name: COOK SPECTRUM
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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: 12220871
• MDR Text Key: 263461206
• Report Number: 1820334-2021-01861
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002508170
• UDI-Public: (01)00827002508170(17)230922(10)13612165
• Combination Product (y/n): Y
• PMA/PMN Number: K081113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2023
• Device Model Number: N/A
• Device Catalogue Number: C-UDLM-801J-ABRM-HC
• Device Lot Number: 13612165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2020
• 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
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 55 KG