MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH-LAB SHEATH INTRO SET:; INTERVENTIONAL PSI PRODUCTS

Catalog Number CL-07624

Device Problems Misconnection (1399); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the catheters are being placed into patient's femorals in the cath lab.The customer claims the locking mechanism on the 6fr, 7fr, and 8fr saf sheaths sometimes does not work.They feel the plastic is either too soft or the locking mechanism does not work between the dilator and the sheath valve assembly.As a result, they have been able to work through the issue.There were no delays in treatment and no patient deaths or complications reported.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed because no sample was returned for analysis.The customer provided a photo of the lidstock.A device history record review was performed and it did not reveal any manufacturing related issues.The probable cause of the dilator easily unlocking could not be determined based upon the information provided and without a sample.No further action will be taken.

Event Description

It was reported the catheters are being placed into patient's femorals in the cath lab.The customer claims the locking mechanism on the 6fr, 7fr, and 8fr saf sheaths sometimes does not work.They feel the plastic is either too soft or the locking mechanism does not work between the dilator and the sheath valve assembly.As a result, they have been able to work through the issue.There were no delays in treatment and no patient deaths or complications reported.

• Brand Name: CATH-LAB SHEATH INTRO SET:
• Type of Device: INTERVENTIONAL PSI PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 6024458
• MDR Text Key: 57294093
• Report Number: 9680794-2016-00175
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: CL-07624
• Device Lot Number: 14F16A0543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2016
• 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