MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CV-25703

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

When passing the central venous catheter, the guide advances in a normal way, when passing the dilator, it folds the guide, being trapped, damaging the guide and preventing the catheter from advancing.This case is presented twice in the same patient with a product of the same reference and the same batch.

Manufacturer Narrative

(b)(4).The customer returned a used kinked spring-wire guide (swg) and a dilator for investigation.Visual and microscopic inspection of the swg revealed the distal end was bent in an l shape with two bends and had multiple offset coils.The distal j-bend had offset coils, but still retained its shape.The distal and proximal welds were intact, full, and spherical.The dilator had no defects or anomalies.Two prominent bends in the swg were located approximately 19 and 35 mm from the distal end of the swg.The guide wire overall length and outer diameter were measured and were found to be within specification.The dilator length and inner diameter of the dilator tip were also found to be within specification.The guide wire was inserted into the distal tip of the dilator and the dilator passed over the entire guide wire with minimal resistance.A manual tug test confirmed that both the distal and proximal welds were intact.The device history records for the dilator and guide wire were reviewed and no relevant manufacturing issues were identified.The instruction booklet provided with the kit describes an insertion procedure including the step to enlarge the cutaneous puncture site with the cutting edge of a scalpel prior to dilating.The customer did not report whether or not this step was performed.The ifu also describes suggested techniques to minimize the likelihood of guide wire damage during use.The report of swg/dilator resistance was confirmed through examination of the returned sample.The swg body had bends and offset coils.Both devices met all dimensional requirements, the swg was able to pass through the dilator during functional testing, and a device history record review did not reveal any manufacturing related issues.Based on the condition of the sample and the report that it occurred during use , it was determined that unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: when passing the central venous catheter, the guide advances in a normal way, when passing the dilator, it folds the guide, being trapped, damaging the guide and preventing the catheter from advancing.This case is presented twice in the same patient with a product of the same reference and the same batch.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 20CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8350087
• MDR Text Key: 136518709
• Report Number: 3006425876-2019-00137
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

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: 03/03/2020
• Device Catalogue Number: CV-25703
• Device Lot Number: 71F18C1409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 03/26/2019
• Supplement Dates FDA Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 80