MAUDE Adverse Event Report: ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN035564
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report number mw5102225.
Event or Problem Description
Complaint found in maude database reported as: "a right ij triple lumen catheter was inserted in a pt with severe sepsis.At the conclusion of the procedure, it was noted the guidewire was retained within the catheter and partially in the ivc.The catheter was not free-floating and was successfully retrieved by ir.Unfortunately, guidewires have a known design "flow" in that there was no hard-stop design measures, other than the professional user, to prevent a guidewire from 'slipping away' into the catheter itself.".
Additional Manufacturer Narrative
Qn#(b)(4).Mdr report key (b)(4).Mdr text key (b)(4).Report number mw5102225.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
Complaint found in maude database reported as: "a right ij triple lumen catheter was inserted in a pt with severe sepsis.At the conclusion of the procedure, it was noted the guidewire was retained within the catheter and partially in the ivc.The catheter was not free-floating and was successfully retrieved by ir.Unfortunately, guidewires have a known design "flow" in that there was no hard-stop design measures, other than the professional user, to prevent a guidewire from 'slipping away' into the catheter itself.".

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• MDR Report Key: 12302964
• Report Number: 1036844-2021-00146
• Device Sequence Number: 14445720
• Product Code: FOZ
• UDI-Device Identifier: 20801902058588
• UDI-Public: 20801902058588
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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: 03/31/2022
• Device Model Number: IPN035564
• Device Catalogue Number: CDC-42703-XP1A
• Device Lot Number: 23F20K0126
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention