MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AM/AT PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER

Catalog Number CDC-41541-MPK1A

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 03/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information received from the user facility: no serious injury.The reporter noted this on the medwatch, but states no serious injury occurred.No intervention required.No adverse event.The device fragment was left in the patient.The doctor determined it may be too risky to remove.The patient had a pacemaker wire in that blocked the fragment from migrating.Patient condition is reported as fine and stable.Patient discharged without incident.

Event Description

According to the medwatch (mw5094242) "glide thru peel away sheath broke at the neck while peeling away causing it to slip beneath the skin.Unable to retrieve".

Manufacturer Narrative

(b)(4).The customer returned one dilator/sheath assembly for evaluation.The device did not appear to be used or damaged, therefore it was assumed a representative sample was provided.Visual examination of the dilator/sheath did not reveal any defects or anomalies.The sheath tabs were fully secured to the sheath extrusion.The total length of the peel-away sheath body measured to be 2.80" which is within specifications of 2.625- 2.875" per product drawing.The inner diameter of the sheath tip measured to be 0.064" which is within specifications of 0.064-0.065" per product drawing.The outer diameter of the sheath body measured to be 0.084" which is within specifications of 0.076-0.086" per product drawing.This indicates that the wall thickness measured within specifications.The returned dilator advanced and retracted from the returned sheath with minimal resistance.A manual tug test confirmed the sheath tabs were fully secured to the sheath body.A device history record review was performed with one potentially relevant finding.A non-conformance was initiated for incorrect sheath peeling.However, the sample returned contained no anomalies so this finding could not be confirmed to be relevant.The instructions-for-use provided with this kit instructs the user, "grasping near skin, advance sheath/dilator assembly with slight twisting motion to a depth sufficient to enter vessel.Note: a slight twisting motion may help sheath advancement.".The customer report of separated sheath tabs could not be confirmed by complaint investigation of the returned sample.The returned representative sample passed all relevant visual, dimensional, and functional testing.A device history record review was performed with no confirmed relevant findings.Without the actual sample to evaluate, this complaint could not be confirmed and probable cause could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

According to the medwatch (mw5094242) "glide thru peel away sheath broke at the neck while peeling away causing it to slip beneath the skin.Unable to retrieve".

• Brand Name: ARROW AM/AT PI MIDLINE 1-L: 4.5FR X 15CM
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10101420
• MDR Text Key: 193436792
• Report Number: 1036844-2020-00164
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• PMA/PMN Number: K161313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: CDC-41541-MPK1A
• Device Lot Number: 23F19M0042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other