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

Catalog Number CS-25703-E

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "md was preparing the procedure and checked the product.Then md found that the swg was bent.So md judged it as a defective product and used new product".No patient involvement reported.

Event Description

The complaint is reported as: "md was preparing the procedure and checked the product.Then md found that the swg was bent.So md judged it as a defective product and used new product".No patient involvement reported.

Manufacturer Narrative

(b)(4).The customer returned one spring wire guide (swg) within the advancer tubing, a 3-l catheter, and a dilator for evaluation.The guide wire cap was not returned with the assembly.Visual examination of the guide wire revealed one kink in the guide wire body in the location over the thumb guide.This portion of the swg would not be protected during shipping, indicating that the guide wire may have been damaged during shipment.Microscopic examination confirmed both welds were present and spherical.The kink in the guide wire body was located at 562 mm from the proximal end.The total length of the guide wire measured to be 603 mm which is within specifications of 596-604 mm per swg product drawing.The outer diameter of the guide wire measured to be 0.799 mm which is within specifications of 0.788-0.826 mm per product drawing.The returned guide wire was advanced through the returned dilator and catheter to functionally test.The swg passed through both with minimal resistance.A manual tug test confirmed both welds were fully intact on the guide wire.A device history record review was performed and no relevant findings were identified.The instructions for use (ifu) provided with the kit informs the user, "do not use if package has been previously opened or damaged." the customer report of guide wire damage before use was confirmed by complaint investigation of the returned sample.The sample passed all relevant dimensional and functional testing, and a device history record review was performed with no relevant findings.The guide wire was returned within its advancer tubing.The tubing showed no kinks or stress marks.The portion of the guide wire that kinked was not protected by the advancer tubing.Based on the condition of the guide wire and the report that the damage was observed before use, storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10872578
• MDR Text Key: 217314038
• Report Number: 3006425876-2020-00967
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2021
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F19G2877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.