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

Catalog Number C-UTLM-701J-RSC-ABRM-HC-RD

Device Problem Flushing Problem (1252)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

Brand name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.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 cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter was found to be occluded immediately after placement in the subclavian.It was reported that, "the blood couldn't be pumpback (withdrawn) during flushing." the physician checked the placement through the blood aspiration.The device was tested prior to use and functioned as intended.The physician removed the catheter and used an alternative device to complete the procedure as intended.As reported, the patient did not experience any adverse effects due to this occurrence.The device was not inspected after removal.No wire kinking, clotting, or device damage was noted.

Event Description

No additional information has been received since the previous medwatch report was submitted.

Manufacturer Narrative

Investigation, evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history records, the instructions for use, manufacturing instructions, and quality control data.The complainant returned one triple lumen abrm coated 7fr 20cm catheter to cook for investigation.Visual examination did not note any major kinks or damage to the device.No damage was noted at the endhole or on the hubs.A 0.032" wire guide was inserted through the catheter tip and exited the red hub.No biomatter came out with wire.A 0.018" wire was inserted through the blue lumen sideport and exited the blue hub.A 0.018" wire was not able to be inserted through the white lumen sideport.The white hub could not be fully flushed.Resistance was experienced when flushing.Some liquid exited the sideport, it was brown in color.The liquid was tested with hemident mammal blood test and the results were positive for blood.Approximate location of the occlusion was approximately 2cm from the most proximal sideport.Both the blue and red lumens flushed without difficulty.The outer diameter of the catheter shaft and the outer diameter of all three extension tubes were measured to be within specification.Investigators could recreate the reported failure mode.Investigators could recreate the reported failure mode.A review of the device history record (dhr) for lot ns8327443 [complete set] records no non-conformances.The dhr for lot ic8081531 [complete catheter] revealed one non-conformance that cook was unable to determine if it was related to this incident.The nonconformance included 3 devices with "abrm in id"; all three devices were scrapped.The dhr for lot ic8102925 [complete catheter] records 2 non-conformances.Cook was unable to determine if the non-conformances were related to this incident.The first non-conformance included 2 devices with "coating in unspecified areas", both devices were scrapped.The second non-conformance mode involved one device with "coating in id", the device was scrapped.Because adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, the non-conforming devices were scrapped 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 definitive conclusion could not be determined.It is possible that the catheter sideport was against the vessel wall and thus obstructed venous aspiration during the procedure.Investigation found resistance when flushing the catheter; however, the portion of liquid that exited the catheter tested positive for blood.It is possible that the resistance experienced while flushing during investigation was dried biomatter within the catheter.The catheter was returned and was found to be occluded in the lumen connected to the white hub.The reported failure could be duplicated.An investigation conclusion could not be established.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.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.

• 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: 8125972
• MDR Text Key: 129589544
• Report Number: 1820334-2018-03471
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002478299
• UDI-Public: (01)00827002478299(17)200726(10)NS8327443
• Combination Product (y/n): N
• 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: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2020
• Device Catalogue Number: C-UTLM-701J-RSC-ABRM-HC-RD
• Device Lot Number: NS8327443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 63