MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIM; MULTI LUMEN ACCESS CATHETERS

Catalog Number CDC-21242-1A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Venipuncture (2129)

Event Date 02/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the clinician was inserting the mac during a heart procedure.During insertion of the sheath/dilator they punctured through the vessel.

Manufacturer Narrative

(b)(4) device evaluation: the reported complaint of during insertion of the mac sheath and dilator assembly the clinician punctured through the vessel could not be confirmed.The customer returned one dilator.The mac sheath was not returned.Visual examination revealed that the dilator was bent and the tip was damaged.The body begins to bend at 11 cm from the hub base.Microscopic examination revealed that the tip was pushed back on one side creating two divots and a flared piece of the tip material.This type of damage can occur with a difficult insertion.The dilator measured 8.78 inches length with an outside diameter (od) of 0.1175inches, which meets the length and od specification for the dilator per graphic.(length: 8.75- 8.875inches and 0.117- 0.120 inches).This report was reviewed; however a comprehensive investigation could not be performed because the sheath was not returned for analysis and very little information was available on this event.The ifu states to enlarge the cutaneous puncture site with a scalpel prior to dilator insertion.It also warns not to leave the tissue dilator in place as an indwelling catheter to minimize the risk of possible vessel wall perforation.Other remarks: information about the skin nick or dilator use was not reported.A device history record review did not reveal any manufacturing related issues.The probable cause of this complaint could not be determined based upon the information provided and without a complete sample.No further action will be taken.

• Brand Name: MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIM
• Type of Device: MULTI LUMEN ACCESS CATHETERS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5505077
• MDR Text Key: 40503236
• Report Number: 1036844-2016-00158
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: CDC-21242-1A
• Device Lot Number: 23F15D1462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/29/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2015
• 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
• Patient Outcome(s): Other