MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PSI KIT: 9 FR; INTRODUCER, CATHETER

Catalog Number AK-09903-JJ

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information: this product is not sold in the us.The 510k # provided is for a similar product that is sold in the us.

Event Description

The customer alleges the dilator tip was damaged.The device was replaced.

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 alleges the dilator tip was damaged.The device was replaced.

Manufacturer Narrative

Qn# (b)(4).The customer returned one dilator/sheath assembly for evaluation.The sample contained signs of use in the form of biological material.The returned dilator was separated and folded back on one side.The folded side contained white coloration, indicating stress.The length and outer diameter of the returned dilator were measured and were found to be within specification.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with this kit instructs the user to perform a skin wheal before dilating skin.The reported complaint of a dilator tip damaged during use was confirmed by complaint investigation.The returned dilator was split and folded on one side.A device history record review was performed with no relevant findings to suggest a manufacturing related issue.Based on the sample received, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The customer alleges the dilator tip was damaged.The device was replaced.

• Brand Name: ARROW PSI KIT: 9 FR
• Type of Device: INTRODUCER, CATHETER
• 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: 7086388
• MDR Text Key: 93832834
• Report Number: 3006425876-2017-00551
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: AK-09903-JJ
• Device Lot Number: 71F17C2343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2017
• 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