MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM BP; CATHETER, INTRAVASCULAR, THERA

Model Number	IPN924166
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Oxygen Saturation (2477)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint is reported as: picc advanced and tip tracker appears to show two circles in the area of right shoulder region.Picc retracted and readvanced with same circles and picc appeared down.White lumen with no blood return.Rn stated the picc stylet "didn't feel right" and removed the picc and stylet.Both the picc and stylet had a bend in it approximately 4-5 inches from the distal tips.The stylet was fully intact and reinserted into the picc.A buddy wire was added into the second lumen.Both lumens were flushed with saline.Picc readvanced and tip tracker did not display the picc advancing.The navicure stylet was removed and replaced with a tip tracker stylet and the t-piece still did not show the advancing of the picc.It was reported the patient was starting to lose a lot of blood and also dropping oxygen saturation.The picc was removed and a capped dilator placed.The vascular positioning system equipment was changed out and picc reinserted.Tip tracker showed picc entering from the right and went down.Lack of blood return from white lumen.Picc retracted 2cm with blood return from both lumens.The patient's oxygen saturation rebounded to an acceptable level and a chest x-ray was obtained.The picc was retracted 6cm and a cat scan of the chest was ordered due to pulmonary changes since picc insertion.Cat scan showed no pneumothorax and picc was in the svc.It was reported there was no injury to the patient and the patient's condition is reported to be fine.
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
The complaint is reported as: picc advanced and tip tracker appears to show two circles in the area of right shoulder region.Picc retracted and readvanced with same circles and picc appeared down.White lumen with no blood return.Rn stated the picc stylet "didn't feel right" and removed the picc and stylet.Both the picc and stylet had a bend in it approximately 4-5 inches from the distal tips.The stylet was fully intact and reinserted into the picc.A buddy wire was added into the second lumen.Both lumens were flushed with saline.Picc readvanced and tip tracker did not display the picc advancing.The navicure stylet was removed and replaced with a tip tracker stylet and the t-piece still did not show the advancing of the picc.It was reported the patient was starting to lose a lot of blood and also dropping oxygen saturation.The picc was removed and a capped dilator placed.The vascular positioning system equipment was changed out and picc reinserted.Tip tracker showed picc entering from the right and went down.Lack of blood return from white lumen.Picc retracted 2cm with blood return from both lumens.The patient's oxygen saturation rebounded to an acceptable level and a chest x-ray was obtained.The picc was retracted 6cm and a cat scan of the chest was ordered due to pulmonary changes since picc insertion.Cat scan showed no pneumothorax and picc was in the svc.It was reported there was no injury to the patient and the patient's condition is reported to be fine.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.

• Brand Name: ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM BP
• Common Device Name: CATHETER, INTRAVASCULAR, THERA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16485998
• Report Number: 9680794-2023-00127
• Device Sequence Number: 6919455
• Product Code: LJS
• UDI-Device Identifier: 10801902208702
• UDI-Public: 10801902208702
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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: 11/30/2023
• Device Model Number: IPN924166
• Device Catalogue Number: DLX-45552-CURVB
• Device Lot Number: 13F22K0020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DLX VASCULAR POSITIONING SYSTEM, 100% OXYGEN; DLX VASCULAR POSITIONING SYSTEM, 100% OXYGEN
• Patient Sex: Unknown