MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH SET: 22 GA X 1-3/8"; WIRE GUIDE CATHETER

Catalog Number RA-04122

Device Problems Device Damaged Prior to Use (2284); Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports the tip of swg (spring wire guide) was found kinked prior to use on patient, which caused the swg could not advance.

Manufacturer Narrative

(b)(4).The sample was not returned; however, the customer provided two photos of radial artery (ra) kits.The photos showed multiple ra kits, some open and others sealed.It was not evident from the photos that the swg within the ra kits were kinked.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit instructs the user, "do not use if package has been previously opened or damaged." the complaint could not be confirmed by the customer's photos.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 the tip of swg (spring wire guide) was found kinked prior to use on patient, which caused the swg could not advance.

Manufacturer Narrative

Qn#(b)(4).The customer returned one, unopened ra cath set for analysis.The seal around between the tray and the lidstock was completely intact.No defects or anomalies were observed with the tray.Before opening the tray, visual analysis revealed that the orange handle on the swg tubing was slightly advanced down the tubing.This resulted in the distal end of the guide wire to protrude out of the tubing.A slight kink was observed on this portion of the guide wire.The kink in the guide wire measured 4mm from the distal end.The guide wire length (according to measurement c in the guide wire w/ handle graphic) measured 4 9/16", which is within the specification limits of 4 7/16"-4 11/16".The guide wire outer diameter measured.382mm, which is within the specification limits of.381mm-.404mm per the guide wire graphic.The guide wire tubing was attached to the needle assembly.The guide wire was advanced through the needle.Resistance was observed due to the kinking; however, the guide wire was eventually able to pass completely through the needle.A device history record review was performed, and no relevant findings were identified.The report of a kinked, arterial guide wire before use was confirmed through complaint investigation.Visual analysis revealed that the returned ra set was completely sealed.The orange handle on the guide wire tubing was slightly advanced forward.This caused the guide wire to protrude from the tubing.A kink was observed on this portion of the guide wire.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, packaging caused or contributed to this event.A non-conformance request was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports the tip of swg (spring wire guide) was found kinked prior to use on patient, which caused the swg could not advance.

• Brand Name: ARROW RA CATH SET: 22 GA X 1-3/8"
• Type of Device: WIRE GUIDE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10033728
• MDR Text Key: 190204890
• Report Number: 9680794-2020-00234
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K810675
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: RA-04122
• Device Lot Number: 14F19A0262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.; UNKNOWN.