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

Catalog Number CL-07824

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges that the dilator is not locked to the sheath with no click sound, and it keeps coming out from the sheath.It is reported that the doctor followed ifu.A new set was used and the procedure was completed successfully.No delay in treatment.No complications.

Manufacturer Narrative

(b)(4).The customer returned one 8 fr.Psi sheath/dilator assembly for evaluation.The valve assembly was found to be separated from the sheath body at the juncture point.The fracture surfaces were microscopically examined and found to have been caused due to excessive force being applied to the assembly.A device history record review was performed and no relevant findings were identified.The customer reported issue of the valve body becoming separated at the sheath juncture was confirmed during the sample investigation.Visual inspection was performed and the separation was determined to have been caused by undue force being applied to the assembly.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 that the dilator is not locked to the sheath with no click sound, and it keeps coming out from the sheath.It is reported that the doctor followed ifu.A new set was used and the procedure was completed successfully.No delay in treatment.No complications.

• 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: 7019590
• MDR Text Key: 92211962
• Report Number: 9680794-2017-00261
• 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: 11/07/2017

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: 07/31/2020
• Device Catalogue Number: CL-07824
• Device Lot Number: 14F15G0316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 12/20/2017
• Supplement Dates FDA Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2015
• 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