MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI PICC KIT: 2-L 5.5 FR X 55 CM AGBA DEL; CATHETER,INTRAVASCULAR,THERAPE

Model Number	IPN056332
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported g4 had no sound or signal so they ended up needing to open a whole new kit just to grab the stylet.After replacing the g4 stylet with a new one the case went fine.No patient harm reported.
Event or Problem Description
Customer reported g4 had no sound or signal so they ended up needing to open a whole new kit just to grab the stylet.After replacing the g4 stylet with a new one the case went fine.No patient harm reported.
Additional Manufacturer Narrative
(b)(4).One vps g4 delta precision stylet assembly, one vps g4 g1+ legacy stylet assembly, and one mc-45552-003c coated cath 2-l: 5.5 fr x 21-21/32" 55cm coated catheter were returned for evaluation.A visual examination of the delta stylet did not reveal any obvious defects or anomalies.A visual examination of the catheter revealed the 55 cm catheter was trimmed to 41 cm with no obvious defects or anomalies.A visual examination of the g1+ stylet revealed kinks at 10 1/2, 11 1/2, 13 1/2, and 15 inches from the end of the santoprene jacket.In addition, the coaxial cable with transducer and the polyimide/ptfe tubing were separated from the main stylet body at approximately 20 3/4 inches from the end of the santoprene jacket.The separated coaxial cable and tubing were located in the returned catheter, indicating no items were left in the patient's vasculature.It was reported "g4 had no sound or signal".Sensitivity testing was performed on the returned delta stylet using pulser receiver and tl-0012-001 stylet holder.Testing was performed per the instructions contained in avep-001318, rev 3.The peak-to-peak echo signal measured 2490 mv, indicating the stylet has acceptable doppler functionality.The reported event "g4 had no sound or signal" was not reproduced using the returned delta stylet.Doppler functionality testing was not performed on the returned g1+ stylet as the damage to the stylet would prevent the transmission of a doppler signal.The reported issue "g4 had no sound or signal" was not confirmed by evaluation of the returned vps g4 delta precision stylet assembly but was confirmed by evaluation of the returned vps g4 g1+ legacy stylet assembly.A visual examination of the delta stylet did not reveal any obvious defects or anomalies.A visual examination of the g1+ stylet revealed kinks at 10 1/2, 11 1/2, 13 1/2, and 15 inches from the end of the santoprene jacket.In addition, the coaxial cable with transducer and the polyimide/ptfe tubing were separated from the main stylet body at approximately 20 3/4 inches from the end of the santoprene jacket.The separated coaxial cable and tubing were located in the returned catheter, indicating no items were left in the patient's vasculature.During functional testing of the delta stylet the peak-to-peak echo signal measured 2490 mv, indicating the stylet has acceptable doppler functionality.Doppler functionality testing was not performed on the returned g1+ stylet as the damage to the stylet would prevent the transmission of a doppler signal.No problem was found with the doppler functionality of the returned delta stylet.Unintentional user error caused or contributed to the inability of the g1+ stylet to provide a doppler signal because the damage to the stylet is a result of unintentional application of undue force by the user during the procedure.Teleflex will continue to monitor and trend reports of this nature.

• Brand Name: ARROW PI PICC KIT: 2-L 5.5 FR X 55 CM AGBA DEL
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11876022
• Report Number: 9680794-2021-00271
• Device Sequence Number: 14279159
• Product Code: LJS
• UDI-Device Identifier: 10801902161724
• UDI-Public: 10801902161724
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K122545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 05/31/2022
• Device Model Number: IPN056332
• Device Catalogue Number: ASK-45552-UWH
• Device Lot Number: 13F21A0331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1