MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 3L 6FRX55CM W/130CM HYDR NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-35563-HPHNL
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the sheath was damaged during use on patient.It was stuck in skin." there was no medical intervention required.The patient's current condition is "unknown" at this time.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The full udi number is not available as complainant did not report a lot number.Additional information received 11jun2024 indicates the tip of the sheath was removed from the patient.No surgical intervention was required.It was also reported that the condition of the patient is "fine".The customer provided one image showing the peel-away with dilator assembly.Visual analysis revealed that the sheath tip was split/ crimped.The dilator body adjacent to the tip was also slightly bent; however, it is likely this occurred as a byproduct of the damage to the sheath tip.The customer also returned one, opened picc kit for analysis.The peel-away sheath with dilator assembly will be analyzed as part of this complaint investigation.Signs of use were observed on the returned sample.Visual analysis revealed that the distal end of the sheath tip was partially damaged/deformed.Slight bending was also noted on the dilator body; however, it is likely that the forces that caused the damage to the sheath tip also resulted in the damage to the dilator body.The sheath length from the tabs to the tip measured 4", which is within the specification limits of 3 7/8"-4 1/8" per the catheter peel-away product drawing.The sheath outer diameter measured 0.1175", which is within the specification limits of 0.1140"-0.1200" per the peel-away extrusion product.The sheath inner diameter at the distal tip could not be accurately measured due to the nature of the damage.The dilator outer diameter measured 0.087", which is within the specification limits of 0.086"-0.088" per the dilator extrusion product drawing.The sheath was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "check peel-away sheath placement by holding sheath in place, twisting dilator hub counterclockwise to release dilator hub from sheath hub, withdraw guidewire and dilator sufficiently to allow blood flow.Holding sheath in place, remove guidewire and dilator as a unit".The dilator was removed and reinserted back into the sheath.The dilator was able to pass through the sheath tip with little to no resistance.R & d and manufacturing have previously been consulted regarding investigations of this nature.They stated that various factors could contribute to the observed damage to the sheath tip, including the sheath tip manufacturing process and/or undue force applied unintentionally by the user.Due to the possibility that manufacturing contributed to this damage, they will further investigate this issue.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not withdraw dilator until sheath is well within vessel to reduce risk of damage to sheath tip".The ifu also states, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to venospasm, vessel perforation, bleeding, or component damage.If necessary, enlarge cutaneous puncture site with cutting edge of scalpel, positioned away from guidewire." the report of a damaged peel-away body was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the sheath tip was split and crimped.Despite the damage, the sheath and the dilator met all relevant dimensional and functional requirements.Various factors could contribute to the observed damage to the sheath tip, including the sheath tip manufacturing process or improper insertion technique during use.Therefore, the root cause cannot be determined at this time.A non-conformance was initiated to further investigate potential root causes at the manufacturing site.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the sheath was damaged during use on patient.It was stuck in skin." there was no medical intervention required.

• Brand Name: ARROW PI PICC 3L 6FRX55CM W/130CM HYDR NIT SWG
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• 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: 19477613
• Report Number: 9680794-2024-00575
• Device Sequence Number: 15221888
• Product Code: LJS
• UDI-Device Identifier: 00801902095640
• UDI-Public: 00801902095640
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K080604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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
• Device Catalogue Number: PR-35563-HPHNL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown