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

Catalog Number CS-25703-E

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.

Event Description

The customer alleges that the guidewire did not straighten out on insertion.A new set was used and the procedure was completed successfully.

Manufacturer Narrative

(b)(4).The customer returned a single guide wire for evaluation.Visual examination revealed the guide wire had one kink at the center of the guide wire body.The guide wire body also had a gradual curve towards the proximal end.The distal j-bend was present and intact.Microscopic examination confirmed the kink in the guide wire body.Both welds were full and spherical.The guide wire body was kinked 11.1cm from the distal tip.The guide wire body was curved between approximately 6-11cm from the proximal tip.The length and outside diameter (od) of the guide wire were measured and found to be within specification.A manual tug test confirmed that both the proximal and distal welds were intact.A device history record (dhr) review was performed on the guide wire and no relevant findings were identified.The 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.Other remarks: the report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire was kinked 11.1cm from the distal tip and had a gradual curve towards the proximal end of the guide wire body.A dhr review was performed on the guide wire and no relevant manufacturing issues were identified.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.

Event Description

The customer alleges that the guidewire did not straighten out on insertion.A new set was used and the procedure was completed successfully.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6646312
• MDR Text Key: 77756441
• Report Number: 3006425876-2017-00188
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/30/2017

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 Expiration Date: 04/30/2018
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F16E1668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/16/2017
• Supplement Dates Manufacturer Received: 07/24/2017
• Supplement Dates FDA Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1