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

Catalog Number AK-09903-AG

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the tip of the dilator bent while being placed.

Manufacturer Narrative

Qn# (b)(4).The customer returned one dilator and lidstock for evaluation.Visual examination revealed the dilator tip was slightly split and compressed, damage consistent with undue force being applied to the dilator tip during an attempted insertion.The overall length of the dilator body measured 6.95" which is within specification of 6.625-7.125" per product drawing.The inner diameter of the dilator tip measured.037" which is within specification of.036-.038" per product drawing.A device history record review was performed with no relevant findings.The ifu provided with this kit instructs the user to perform a skin wheal prior to dilating the skin.The customer report of a damaged dilator tip was confirmed by complaint investigation of the returned sample.The dilator tip was slightly split and compressed, damage consistent with undue force being applied to the dilator tip during an attempted insertion.A device history record review was performed with no relevant findings.Based on the sample provided, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The customer reports that the tip of the dilator bent while being placed.

• Brand Name: ARROW PSI KIT: 9 FR
• Type of Device: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9099888
• MDR Text Key: 177676866
• Report Number: 9680794-2019-00359
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K011761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: AK-09903-AG
• Device Lot Number: 13F17G0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1