MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI KIT 9 FR X 4"; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number ASK-21142-UW

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was received by the manufacturer, but the investigation is in progress at the time of this report.The lot number reported in this complaint is from the sample received.

Event Description

The customer reports that they could not remove guidewire.They removed the dilator and was able to remove and discovered that the wire was kinked.No patient injury or consequence.

Manufacturer Narrative

(b)(4).The customer returned a guide wire and a sheath for evaluation that showed evidence of use.The guide wire was returned advanced through the hemostasis valve of the sheath.The dilator was not returned.Visual examination of the guide wire revealed two kinks adjacent to each other on the body.The j-bend on the distal tip was intact and no other damage was observed.The sheath showed evidence of use but no damage or anomalies were observed.Microscopic examination revealed one of the kinks had separated coils and that both welds were full and spherical.Microscopic examination of the sheath did not reveal any damage.The two kinks in the guide wire body were located 34.5 and 35.0cm from the proximal tip.The guide wire overall length measured 452mm which is within specification.The outside diameter (od) of the guide wire was also measured and found to be within specification as well.The guide wire was able to pass through the sheath with minimal resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record (dhr) review was performed on the guide wire and dilator and no relevant issues were identified.Other remarks: the reported complaint of the guide wire becoming kinked during insertion with the dilator was confirmed through visual inspection of the returned sample.Two kinks were observed on the returned guide wire; however, the dilator was not returned for evaluation.A dhr review did not reveal any manufacturing related issues.The probable cause of the guide wire kinking could not be determined based upon the information provided and without a complete sample.

Event Description

The customer reports that they could not remove guidewire.They removed the dilator and was able to remove and discovered that the wire was kinked.No patient injury or consequence.

• Brand Name: ARROW MULTI-LUMEN/PSI KIT 9 FR X 4"
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: 6587689
• MDR Text Key: 75872658
• Report Number: 1036844-2017-00206
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: ASK-21142-UW
• Device Lot Number: 23F16C0676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2016
• 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