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

Model Number	G50817
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Brand name: cook spectrum minocycline/rifampin impregnated double lumen central venous catheter.(b)(4).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
It was reported by the customer that after the placement of the cook spectrum minocycline/rifampin impregnated double lumen central venous catheter the catheter became occluded.The device was replaced successfully with another device in the same procedure.
Additional Manufacturer Narrative
Device evaluation: the complainant returned the double lumen catheter and wire guide to the manufacturer for investigation.The investigation of the wire guide will be reported under mfr.Report: 1820334-2019-00347.A physical examination of the device showed the device to be in a damaged and used condition, with biological matter present in the extension tube with the red hub and visible through the sideport.Dimensional verification of the catheter¿s endhole diameter and outer diameter confirmed these measurements to be within manufacturing specifications.The catheter¿s inner diameter could not be measured since the catheter is tapered at the distal end and not exposed at the proximal end.An occlusion test was performed to test the reported failure mode of occlusion.Using a syringe with water, both the lumens were found to be able to pass water.The lumen with the red hub passed water with a little more difficulty, potentially due to some occlusion.Investigation: a document-based investigation reviewed the following: complaint history, device history record, instructions for use, manufacturing instructions, and quality control specifications the device history record (dhr) of lot ns8697842 showed no nonconformances.Related subassembly lots ic8530069 and ic8343585 showed no nonconformances related to the failure mode in this complaint.A search of the manufacturer's complaint database revealed one other complaint under this lot number (mfr.Report: 1820334-2019-00347).This complaint was opened due to an incidental finding regarding the wire guide that was returned under this complaint, and thus concerns a separate failure mode.Since there are no related nonconformances and no other complaints with the same failure mode from this lot, there is no evidence that nonconforming product exists in house or in the field.(b)(4).¿ clinical assessment: at this time, the most probable causes of this event are medical procedure or device failure related.Conclusion: based on the information provided, examination of the returned product, and the results of our investigation, the main root cause could not be determined but the possible root cause was determined to be cause cannot be traced to device (adverse event related to patient condition).Per the [quality engineering] risk assessment, no further action is required.The appropriate personnel were notified, and we will continue to monitor for similar complaints.
Event or Problem Description
No new event description information to report at this time.

• Brand Name: COOK SPECTRUM
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8233559
• Report Number: 1820334-2019-00019
• Device Sequence Number: 18886212
• Product Code: FOZ
• UDI-Device Identifier: 00827002508170
• UDI-Public: (01)00827002508170(17)201211(10)NS8697842
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K081113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2020
• Device Model Number: G50817
• Device Catalogue Number: C-UDLM-801J-ABRM-HC
• Device Lot Number: NS8697842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 02/28/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 65