MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIM; INTRODUCER CATHETER

Catalog Number CDC-21242-1A

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The preliminary evaluation of the returned sample indicates the swg deformed (kink).Lot# of returned device - 13f18e0426.

Event Description

The customer reports the guidewire got stuck in the raulerson syringe and would not advance through the introducer needle.Customer pulled everything out at the same time.A delay was reported without incident.

Manufacturer Narrative

Qn#(b)(4).The customer returned a single guide wire assembly, an introducer needle and the product lidstock for evaluation.The guide wire was returned retracted within the advancer tube with the distal end advanced into the needle cannula.The components showed evidence of use.The guide wire was able to be removed from the needle cannula and it was observed to have a slight kink towards the distal end of the body.The distal j-bend was misshapen but intact.No damage was observed with the introducer needle but dried blood was observed within the hub.Microscopic examination confirmed the slight kink in the guide wire body.Both welds were present and were observed to be full and spherical.Dried blood was observed on the portion of the guide wire body that was within the needle cannula.The slight kink in the guide wire was located 5 mm from the distal tip.The overall length and outer diameter of the guide wire were measured and were found to be within specification.The inner and outer diameter of the needle cannula were also found to be within specification.The guide wire was returned with the distal end stuck within the needle cannula, however, it was able to be removed without further damage.The needle was flushed with water and dried blood was observed coming out of the cannula.After the needle was flushed, the guide wire was able to pass through the needle with minimal resistance.A manual tug test confirmed that both the distal and proximal welds were intact.The customer did not supply a lot number but a potential lot was determined from a sales history review for this customer.A device history record review was performed on the guide wire and insertion components (ars and needle) and no relevant findings were identified.The instructions-for-use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.The report of resistance between the guide wire and introducer needle was confirmed through examination of the returned sample.The guide wire was stuck within the needle due to dried blood within the cannula.After the blood was flushed out, the guide wire was able to pass through the needle as expected.The returned guide wire and introducer needle met all relevant dimensional/functional requirements and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports the guidewire got stuck in the raulerson syringe and would not advance through he introducer needle.Customer pulled everything out at the same time.A delay was reported without incident.

• Brand Name: ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIM
• Type of Device: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7805670
• MDR Text Key: 117962894
• Report Number: 3003737899-2018-00095
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K011761
• 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: 08/22/2018

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: Health Professional
• Device Catalogue Number: CDC-21242-1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: 09/18/2018
• Supplement Dates FDA Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1