MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AM PICC SET: 2-L 5.5FR X 55CM 130CM HYDR; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number CS-25123-F

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was received by the manufacturer, but the investigation is not complete at the time of this report.

Event Description

The customer alleges that during insertion, the spring wire guide kinked.

Manufacturer Narrative

(b)(4).The customer returned a single guide wire and the product lidstock for evaluation.It was observed that there was one significant kink at the center of the guide wire body.The guide wire between the kink and the distal tip was curled and twisted.The distal tip was intact but did not retain its j-bend shape.Microscopic examination confirmed the kink in the guide wire body.Both welds were present and were observed to be full and spherical.The guide wire was kinked 36.6cm from the proximal tip.The guide wire was twisted/curled between 36.6-54.9cm from the proximal tip.The overall length and outer 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 catheter and no relevant manufacturing issues 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.Other remarks: the report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire was kinked at the center of the body and twisted/curled towards the distal end.The returned guide wire met all relevant dimensional requirements.A dhr review was performed and 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.

Event Description

The customer alleges that during insertion, the spring wire guide kinked.

• Brand Name: ARROW AM PICC SET: 2-L 5.5FR X 55CM 130CM HYDR
• 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: 6756970
• MDR Text Key: 81498402
• Report Number: 3006425876-2017-00236
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: CS-25123-F
• Device Lot Number: 71F16L2183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• 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