MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PICC 2-LUMEN 5.5 FR X 55CM; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number ASK-45552-LVH1

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: during insertion of the picc line it was observed that the sheath tip was damaged.There was no patient injury or consequence.The condition of the patient is reported as "fine".

Event Description

The complaint is reported as: during insertion of the picc line it was observed that the sheath tip was damaged.There was no patient injury or consequence.The condition of the patient is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The customer returned one peel-away sheath for evaluation.Visual examination of the sheath revealed the tip was frayed outwards.The tip also contained white coloration.This damage is consistent with undue force being applied to the sheath tip during an attempted insertion.The total length of the sheath body measured to be 2.75" which is within specifications of 2.625-2.875" per product drawing.The outer diameter of the sheath body measured to be 0.099" which is within specifications of 0.094-0.104" per product drawing.The inner diameter of the distal tip could not be measured due to the damage observed.The returned dilator was able to advance and retract from the returned sheath with minimal resistance.A device history record review was performed with no relevant findings.The ifu provided with this kit cautions the user, "do not withdraw dilator until sheath is within vessel to minimize the risk of damage to sheath tip." the ifu also instructs the user to "enlarge puncture site, if necessary" using a scalpel prior to insertion of the sheath.This would mitigate the potential for damage to the sheath tip during insertion.The customer did not state whether this was performed.The ifu also provides technique suggestions for the sheath insertion: "thread tapered tip of peel-away sheath/dilator assembly over guidewire.Grasping near skin advance assembly with slight twisting motion to a depth sufficient to enter vessel.Dilator may be partially withdrawn to further facilitate advancement of sheath into the vessel.A slight twisting motion of the peel-away might help sheath advancement." the customer report of a damaged sheath tip was confirmed by complaint investigation of the returned sample.The peel-away sheath tip was frayed and contained damage consistent with undue force being applied during insertion.The sample passed all relevant dimensional and functional testing, and a device history record review was performed with no relevant findings.Based on the condition of the sample received and the customer report of the defect being identified during use, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW PICC 2-LUMEN 5.5 FR X 55CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10813321
• MDR Text Key: 215527595
• Report Number: 1036844-2020-00288
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K112896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

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 Operator: No Information
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: ASK-45552-LVH1
• Device Lot Number: 23F20G0312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1