MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 20GA X 5CM; CATHETER, PERCUTANEOUS

Catalog Number SAC-00520

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 01/26/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It is reported that the swg (spring wire guide) was kinked in the package.

Event Description

It is reported that the swg (spring wire guide) was kinked in the package.

Manufacturer Narrative

(b)(4).The customer returned one unopened sac kit for analysis.The guide wire and the guide wire tubing will be analyzed as part of this complaint investigation.Visual analysis revealed that the guide wire contained one distinct kink.With the guide wire fully inserted, microscopic examination revealed white stress marks on the tubing at the same location as the kink.The damage observed is consistent with defects related to shipping and handling.No other defects or anomalies were observed.The kink in the guide wire measured 85mm from the distal weld.The guide wire total length measured 350mm, which is within the specification limits of 345mm-355mm per the guide wire graphic.The guide wire outer diameter measured.517mm, which is within the specification limits of.508mm-.533mm per the guide wire graphic.A device history record review was performed, and no relevant findings were identified.The returned product label/lidstock was also analyzed as part of this complaint investigation.The words "do not bend" were clearly listed at the top and bottom.The report of a kinked guide wire was confirmed through complaint nvestigation.Visual analysis of the contents within the opened kit revealed that the guide wire was kinked.Stress marks were also observed on the guide wire tubing at approximately the same location as the kink.The guide wire met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the report from the customer and the sample received, storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Manufacturer Narrative

Qn#(b)(4).The customer did not return a complaint sample; however, they supplied three photos showing a kinked guide wire inside the packaging, and lidstocks.The guide wire appears to be kinked in the middle of the body, but it cannot be determined without the sample to evaluate.A probable cause of the guide wire kinking is shipping and storage related; however it cannot be determined from the photos and without the sample to evaluate.The photo from the customer contains "do not bend" on the lidstock.A device history record review was performed with no evidence to suggest a manufacturing related cause.The report that the guide wire was kinked in packaging was confirmed through examination of the customer supplied photos.The images showed the guide wire kinked in the package.One of the photos also showed the lidstock containing the words "do not bend".This type of damage is usually a result of improper shipping and storage.However, the actual complaint sample was not returned for evaluation.The device history records for the guide wire and finished kit was reviewed with no evidence to suggest a manufacturing related cause.The probable cause of the guide wire damage could not be determined based upon the information provided and without the actual complaint sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It is reported that the swg (spring wire guide) was kinked in the package.

• Brand Name: ARROW ARTERIAL CATH SET: 20GA X 5CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9681998
• MDR Text Key: 180321841
• Report Number: 3006425876-2020-00134
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K093050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: SAC-00520
• Device Lot Number: 71F19J1693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1