MAUDE Adverse Event Report: TELEFLEX MEDICAL ARROW ARTERIAL LINE KIT; PERCUTANEOUS ATRIAL CATHETER KIT

Catalog Number AK-04510-S

Device Problems Positioning Failure (1158); Failure to Advance (2524); Folded (2630)

Patient Problems Low Blood Pressure/ Hypotension (1914); Diminished Pulse Pressure (2606)

Event Date 07/17/2014

Event Type  malfunction  

Event Description

Pt was a new trauma with multiple broken bones.In er, four lumen central line placed to the rt groin that folded back on itself.Four lumen central line then placed in the right subclavian with much difficulty.Pt had low blood pressure and femoral pulse that was weak.Resident attempted femoral arterial line and unable to thread wire.Attending attempted arterial line multiple times and unable to thread wire through needle.Once wire was threaded then unable to advance catheter over wire into the site.Had good arterial flow, wire attempted both ways and still unable to advance wire.New kit obtained, wire advanced easily with new wire.Attempted to insert old wire into needle from new kit once line placed and dressed.Wire very hard to insert but could force through x 1.Wire saved.Arrow arterial line kit, lot number 23f14e1034.After the doctor got the needle into the artery the wire would not advance.Much work getting it into the artery; but when a new wire was used it threaded easily.Additional info from the rn involved in the case: both kits (the one that worked and the one that didn't work) had the same lot #s.The rn thinks the incident is part from the anatomy of the patient because all extemities were broken in the trauma event, including ribs and pelvis.However, the rn also thinks the wire could be defective.
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manufacturer response for femoral arterial line, (brand not provided) (per site reporter).
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we have not heard back from them.

• Brand Name: ARROW ARTERIAL LINE KIT
• Type of Device: PERCUTANEOUS ATRIAL CATHETER KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; p o box 12600; durham NC 27709
• MDR Report Key: 3973071
• MDR Text Key: 15909455
• Report Number: 3973071
• Device Sequence Number: 1
• Product Code: DQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/22/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: AK-04510-S
• Device Lot Number: 23F14E1034
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OTHER
• Patient Age: 42 YR
• Patient Weight: 64