MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"; CATHETER,INTRAVASCULAR,THERAP

Catalog Number ASK-45703-PSJR

Device Problems Break (1069); Sticking (1597)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Patient's current condition is reported as fine.

Event Description

The customer reports: triple lumen was attempted in left ij in emergency room.The guidewire was stuck after passing through needle.Needle and wire were removed but piece of wire remained in patient.It was not determined until after the procedure that wire had broken.Access was obtained in another site.Intervention required: surgery to remove the separated swg.

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.

Event Description

The customer reports: triple lumen was attempted in left ij in emergency room.The guidewire was stuck after passing through needle.Needle and wire were removed but piece of wire remained in patient.It was not determined until after the procedure that wire had broken.Access was obtained in another site.Intervention required: surgery to remove the separated swg.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7596580
• MDR Text Key: 111003266
• Report Number: 1036844-2018-00167
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: ASK-45703-PSJR
• Device Lot Number: 23F18A0547
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention