MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB+; CATHETER,INTRAVASCULAR,THERAP

Catalog Number ASK-45703-PUMC

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The preliminary evaluation of the returned device indicated the dilator (not sheath) had evidence of use in the form of dried blood and tip of dilator damaged (split).

Event Description

The customer alleges the tip of the introducer noted to be frayed/split/bent upon removal from package.A new kit was used.

Manufacturer Narrative

(b)(4).The customer returned one used dilator for evaluation.The tip of the dilator was found to be deformed.Part of the tip material was pulled to the side, indicating interaction with a spring-wire guide.The dilator body measured 3 15/16 inches in length , which is within specification.A device history record review was performed and no relevant findings were identified.The instructions-for-use (ifu) that are packaged with this product suggest using the cutting edge of a scalpel to enlarge the cutaneous puncture site if needed.The customer reported issue of the dilator tip becoming damaged was confirmed during the sample investigation.Visual inspection was performed and the dilator was determined to have been damaged due to interaction with the spring-wire guide during the procedure.A device history record review was performed and no relevant findings were identified.Based on the information provided and the condition of the returned sample the probable cause of this issue is operational context.

Event Description

The customer alleges the tip of the introducer noted to be frayed/split/bent upon removal from package.A new kit was used.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB+
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• 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: 7196000
• MDR Text Key: 97777482
• Report Number: 1036844-2018-00016
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: ASK-45703-PUMC
• Device Lot Number: 23F17C0378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2017
• 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