MAUDE Adverse Event Report: COOK INC SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device available for eval: device return information is unavailable at the time of this report.(b)(6).Occupation: unknown.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 that the wire in a single lumen peripherally inserted central venous catheter set was thinner than usual which resulted in a piece breaking off in the patient during use.The physician was placing a picc line when it was noticed that part of the wire seemed thinner than the rest.The wire broke inside the patient, which required the physician to cut down a vein to remove the wire.The patient is reported to be doing well.Additional information regarding device and event details has been requested but is unavailable at this time.
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
Investigation - evaluation.A review of the documentation including the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi) 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, photos of the device were provided.The images compare the complaint device to another device.There is indication of wire elongation on the complaint device.There is no evidence to suggest that product was not manufactured to current specifications.Additionally, a document-based investigation evaluation was performed.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The proper risk controls are in place to ensure this does not occur, including mechanical testing, manufacturing instructions and quality control specifications.This analysis indicates that the risks associated with the devices are acceptable when weighed against the benefits.A review of the dhr for the complaint lot (9772071) and the related wire guide sub-assembly lot (ic9637709) revealed no non-conformances.A database search found this to be the only event associated with the provided complaint lot.As there are adequate inspection activities established, objective evidence that the dhr was fully executed, no non-conformances, and no additional complaints from the same lot, cook has concluded that there is no evidence to suggest that nonconforming product exists either in house or in field.Cook also reviewed product labeling.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: standard technique for placement of vascular access sheaths, catheters and wire guides should be employed.Catheter placement (fluoroscopic method): using fluoroscopic guidance, introduce the wire guide through the needle and advance it 15-20cm into the vessel.Withdraw the needle, leaving wire guide in place.Introduce the peel-away introducer assembly (sheath and dilator) over the wire guide.Catheter placement (non-fluoroscopic method): introduce the wire guide through the needle and advance it 15-20cm into the vessel.Withdraw the needle, leaving wire guide in place.Introduce the peel-away introducer assembly (sheath and dilator) over the wire guide.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.There is product warning label on the wire guide holder l_scor_rev 0 depicting a warning to not pull the distal spring coil portion of the wire guide through the needle tip.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be established.It is unknown if the wire was manipulated through the needle.If the wire guide contacts the sharp bevel of the needle during repositioning or upon removal it can cause elongation of the wire guide.In addition, the anatomy of the patient with thrombophlebitis may have contributed to this incident.Therefore, the investigation conclusion for this complaint is cause traced to a component failure.The appropriate personnel have been notified.Per the quality engineering 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.

• Brand Name: SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
• 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: 9284442
• Report Number: 1820334-2019-02798
• Device Sequence Number: 16175295
• Product Code: FOZ
• UDI-Device Identifier: 00827002083783
• UDI-Public: (01)00827002083783(17)220529(10)9772071
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K950118
• 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
• Report Date (Section B): 02/03/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/29/2022
• Device Model Number: N/A
• Device Catalogue Number: PICS-501-MPIS
• Device Lot Number: 9772071
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention