MAUDE Adverse Event Report: ARROW INTERNATIONAL INC.; CATHETER PERCUTANEOUS

Catalog Number CL-07845

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Brain Injury (2219)

Event Date 05/05/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports that during insertion the doctor found the tip of the dilator was torn.The doctor judged the product as a defective product.Therefore, the doctor finished using the same product without any abnormality.

Manufacturer Narrative

Qn#(b)(4).The customer returned one cath-lab sheath intro set with the dilator inserted for evaluation.Visual inspection of the dilator revealed that it had a deformed tip.The tip was torn and compressed.Microscopic examination confirmed the damaged dilator tip.This damage is consistent with undue force being applied to the dilator tip.The length of the dilator body measured 21.0" , which is within specifications of 20.875-21.375" per dilator graphic.The outer diameter of the dilator body measured 0.10890" which is within specifications of 0.107-0.110" per dilator graphic.The inner diameter of the dilator tip was unable to be measured due to the damage on the sample.A device history record review was performed with no relevant findings.The ifu provided with this kit instructs the user, "do not apply excessive force in removing guide wire or sheath/dilator.If withdrawal cannot be easily accomplished, determine cause using fluoroscopic guidance and request further consultation, if necessary." the customer report of a damaged dilator tip was confirmed by the complaint investigation of the returned sample.The dilator tip was torn and compressed, which is 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 use 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 during insertion the doctor found the tip of the dilator was torn.The doctor judged the product as a defective product.Therefore , the doctor finished using the same product without any abnormality.

• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10066699
• MDR Text Key: 191380986
• Report Number: 9680794-2020-00242
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: CL-07845
• Device Lot Number: 14F18L0177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1