MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CATH-LAB SHEATH INTRO SET; CATHETER, PERCUTANEOUS

Catalog Number CL-07824

Device Problems Break (1069); Connection Problem (2900); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges the doctor found that the dilator is not locked to the sheath with no click sound, and it keeps coming out from the sheath.The md tried many times, and then the upper part of the dilator broke.A new set was used and the procedure was successfully completed.

Manufacturer Narrative

Qn# (b)(4).The customer returned one sheath/dilator assembly and lid stock from a cl-07824 kit.Visual inspection was performed on the sheath/dilator assembly and the hub of the dilator was found to be separated from the dilator body at the base of the hub.Some damage was noticed around the locking area of the hub; likely caused by the repeated insertions by the physician.The outer diameter of the lower locking portion of the dilator hub measured 0.146 inches, which does not meet specification.The inner diameter of the sheath valve cap was found to be within specification.The dilator hub would not snap into the sheath cap and required little force to be removed.A device history record (dhr) review was performed and no relevant findings were identified.The customer reported issue of the dilator and sheath not locking together was confirmed during the complaint investigation of the returned sample.The dilator hub would not fully snap into the sheath cap and required little force to be removed during functional testing.The outer diameter of the lower locking portion of the dilator hub measured out of tolerance during dimensional testing; therefore, the probable cause of this issue is manufacturing related.A capa was previously generated to further investigate this issue.

Event Description

The customer alleges the doctor found that the dilator is not locked to the sheath with no click sound, and it keeps coming out from the sheath.The md tried many times, and then the upper part of the dilator broke.A new set was used and the procedure was successfully completed.

• Brand Name: ARROW CATH-LAB SHEATH INTRO SET
• Type of Device: CATHETER, PERCUTANEOUS
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6827463
• MDR Text Key: 83883611
• Report Number: 9680794-2017-00162
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: CL-07824
• Device Lot Number: 14F14L0382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2017
• Initial Date FDA Received: 08/29/2017
• Supplement Dates Manufacturer Received: 10/09/2017
• Supplement Dates FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2014
• 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