MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number CS-27702-E

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges that the spring wire guide (swg) kinked during insertion.No patient harm reported.A new kit was used.

Manufacturer Narrative

(b)(4).The customer returned a single guide wire for evaluation.A visual exam was performed and it was observed that the guide wire had one significant kink at the center of the guide wire body and another slight kink towards the proximal end of the guide wire body.Microscopic examination confirmed both of the kinks.Both welds were present and were observed to be full and spherical.No damage was observed to the distal tip j-bend.The first significant kink was located 26.7cm from the proximal tip and the second slight kink was located 15.7cm from the proximal tip.The outside diameter (od) of the guide wire measured 0.817 mm, which met specification.The overall length of the guide wire was also 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, catheter, and insertion components, and no relevant findings 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 body was kinked in two locations; 26.7cm and 15.7cm from the proximal tip.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 the spring wire guide (swg) kinked during insertion.No patient harm reported.A new kit was used.

• Brand Name: ARROW CVC SET: 2-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: 6630072
• MDR Text Key: 77282707
• Report Number: 3006425876-2017-00183
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F16F0600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2016
• 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