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

Catalog Number CL-07624

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges that the md found the dilator is not locked to the sheath with no click sound and it keeps coming out from the sheath.The medical doctor used a new set and the procedure was completed successfully.

Manufacturer Narrative

Qn# (b)(4).The customer returned a sheath/dilator assembly for evaluation with the dilator advanced into the sheath.The assembly was visually inspected and showed no obvious defects or anomalies.The outer diameter of the lower locking portion of the dilator hub was measured and did not meet specification.The inner diameter of the sheath valve cap, the overall dilator length, and the outer diameter of the dilator body were measured and found to be within specification.The dilator would not snap into the sheath hub and required little force to be removed.A device history record review was performed and did not suggest any manufacturing related issues.The customer reported issue of the dilator and sheath not locking together was confirmed during the complaint investigation of the returned sample.The dilator would not fully snap into the sheath hub 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 that the md found the dilator is not locked to the sheath with no click sound and it keeps coming out from the sheath.The md used a new set and the procedure was completed successfully.

• 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: 6801096
• MDR Text Key: 82928822
• Report Number: 9680794-2017-00144
• 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: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• 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: 14F16B0200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2016
• 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