MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PICC SET: 4 FR X 19-1/2" (50 CM); CATHETER,INTRAVASCULAR,THERAP

Catalog Number PR-05041

Device Problems Unraveled Material (1664); Physical Resistance (2578)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: picc line insertion under ultrasound guidance.Insertion of wire with mild resistance felt.Unable to remove guidewire.Attempt to remove both introducer needle and wire.The wire was stuck in the tissue.Wire unraveled and unable to remove at the time despite interventional radiology assistance.Intervention - later, surgically removed (as in tissue external to vein).Nil adverse outcome.

Event Description

The customer reports: picc line insertion under ultrasound guidance.Insertion of wire with mild resistance felt.Unable to remove guidewire.Attempt to remove both introducer needle and wire.The wire was stuck in the tissue.Wire unraveled and unable to remove at the time despite interventional radiology assistance.Intervention - later, surgically removed (as in tissue external to vein).Nil adverse outcome.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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 PICC SET: 4 FR X 19-1/2" (50 CM)
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7528654
• MDR Text Key: 108733992
• Report Number: 9680794-2018-00119
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K042126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/08/2018

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
• Device Operator: No Information
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: PR-05041
• Device Lot Number: 14F16H0646
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/20/2018
• Supplement Dates Manufacturer Received: 06/21/2018
• Supplement Dates FDA Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention