MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CDC-45703-XP1A

Device Problems Bent (1059); Difficult to Insert (1316); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges that the doctor could not insert the spring wire in the course of action the wire bent.The entire wire was removed from the patient without an event.

Manufacturer Narrative

(b)(4).The customer returned a single guide wire for evaluation.The guide wire was returned within the advancer tube and showed evidence of use.The guide wire was observed to have a gradual bend/kink towards the distal end of the body.The distal j-bend was slightly deformed but intact.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/bent from 3.1-4.2cm from the distal tip.The overall length and outer diameter (od) of the guide wire were found to be within specification.The guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guide wire.The guide wire passed through both components with minimal resistance.A manual tug test confirmed both the distal and proximal welds are intact.A dhr review was performed on the guide wire and insertion components 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.The report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire had a bend/kink between 3.1-4.2cm from the distal tip.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 the doctor could not insert the spring wire in the course of action the wire bent.The entire wire was removed from the patient without an event.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6795390
• MDR Text Key: 82782158
• Report Number: 1036844-2017-00305
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 23F17D0388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2017
• 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