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 Kinked (1339); Material Too Rigid or Stiff (1544); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports the doctor having issue with the guide wire.It becomes very stiff and difficult to pass through the introducer.In some cases, it is so difficult that they can't pass it though ending up kinking.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports the doctor having issue with the guide wire.It becomes very stiff and difficult to pass through the introducer.In some cases, it is so difficult that they can't pass it though ending up kinking.

Manufacturer Narrative

(b)(4).The customer returned one guide wire for evaluation.The introducer needle was not returned.Visual examination revealed the guide wire body was kinked/bent near the center.The distal j-bend was undamaged.Microscopic examination of the guide wire confirmed the kink and revealed offset coils at the location of the kink.Both welds appeared intact, full and spherical.The kink (with offset coils) in the guide wire body was located approximately 244 mm from the proximal weld.The overall length and outer diameter of the guide wire were measured and were found to be within specification.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this kit describes suggest techniques for insertion to minimize damage to the guide wire 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 reported complaint of the guide wire becoming kinked while using the introducer needle was confirmed through visual inspection of the returned sample.A single kink was observed on the returned guide wire; however, the introducer needle was not returned for evaluation.A device history record review did not reveal any manufacturing related issues.No manufacturing defects were found during this investigation.Based on these circumstances, operational context likely contributed to this event, however, the probable cause of guide wire and needle resistance could not be determined based upon the information provided and without the needle being returned.

Event Description

The customer reports the doctor having issue with the guide wire.It becomes very stiff and difficult to pass through the introducer.In some cases, it is so difficult that they can't pass it though ending up kinking.

• 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: 7513931
• MDR Text Key: 108252982
• Report Number: 1036844-2018-00143
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2018

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: 04/30/2019
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 23F17L0792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 06/19/2018; 08/16/2018
• Supplement Dates FDA Received: 06/20/2018; 08/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2017
• 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