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

Model Number G47829

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Anaphylactic Shock (1703)

Event Date 07/12/2020

Event Type  Injury  

Manufacturer Narrative

Brand name: cook spectrum minocycline / rifampin impregnated triple lumen central venous catheter set a follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that after the insertion of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter the patient experienced anaphylactic shock.The device was inserted into the right femoral vein and the catheter tip location was confirmed by x-ray, immediately after insertion, the patient suffered anaphylactic shock.The physician removed the device.After the removal of the device the anaphylaxis continued for 30 minutes.During this time medications administered included bosmin, levophed, and gelofusine 250ml.The patient then became stable and the physician used a competitor's device to complete the placement of a central venous catheter.The patient did not have a pre-existing diagnosed allergy.

Event Description

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

Manufacturer Narrative

Correction: d10, h3, h6- device code.Investigation - evaluation.It was reported that a patient experienced anaphylactic shock after use of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set (c-utlm-701j-rsc-abrm-hc-rd) from lot 9676480.The patient experienced shock immediately after the catheter was placed in the right femoral vein.Cook became aware of this event on 21sep2020 upon being notified by (b)(6) hospital.The patient eventually stabilized and experienced no additional adverse effects as a result of this incident.A review of the complaint history, device history record (dhr), instructions for use (ifu) and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history records (dhrs) for the reported complaint device lot (9676480) and the related catheter subassembly lot revealed no recorded non-conformances.A database search identified one additional complaint for the device lot concerning a different failure mode.Cook has concluded that the device was manufactured to specification and that there is no evidence suggesting that nonconforming product exists either in house or in field.Cook also reviewed product labeling.Instructions for use (ifu) document [cook spectrum central venous catheter minocycline/rifampin antibiotic impregnated power injectable] is packaged with this device.The product ifu states the following in consideration of the reported failure mode: ¿contraindications: allergy or history of allergy to tetracyclines (including minocycline) or rifampin.Minocycline and rifampin are agents that do not induce any genotoxic risks except a possible teratogenic effect in pregnant women.We therefore do not recommend the use of spectrum or spectrum glide catheters in pregnant women.How supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile¿.Upon removal from package, inspect the product to insure no damage has occurred.¿ based on the information provided, no product returned, and the results of the investigation, a definitive root cause for this event was unable to be established.The customer reported that the patient has no past history of allergy, yet the patient experienced anaphylactic shock.Various medications were administered during the use of this device, so a definitive cause of failure cannot be determined without additional information.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment 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.

• 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
• MDR Report Key: 10643821
• MDR Text Key: 214801378
• Report Number: 1820334-2020-01816
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002478299
• UDI-Public: (01)00827002478299(17)220206(10)9676480
• Combination Product (y/n): Y
• PMA/PMN Number: K081113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2022
• Device Model Number: G47829
• Device Catalogue Number: C-UTLM-701J-RSC-ABRM-HC-RD
• Device Lot Number: 9676480
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 65