MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI PICC: 2-L 5FR X 50CM W/ 80CM HYDRO; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number PR-35052-HPHNM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges that during insertion of the sheath/dilator over wire, the nurse felt something sharp approximately 2cm from the distal end of the sheath.Another device was used without issue.

Manufacturer Narrative

(b)(4) the customer returned a peel-away sheath with dilator inserted for evaluation.The components showed evidence of use.Visual examination of the returned sheath body revealed damage along both score lines.Microscopic examination of the sheath revealed that one side the body is rippled/deformed along the score line of the body towards the distal tip.Microscopic examination revealed that the rippled areas in the score line were also under stress since the material is stretched and white in color.The material is raised and deformed.The sheath tip showed evidence of use, however, no damage was observed.The deformed sheath body material is located 1.7cm from the distal tip and is 0.6cm in length.The sheath length measured 10.2cm from the hub to the distal tip, which is within specification.The sheath tip inner diameter (id) and the dilator length (from the hub to the distal tip) were also found to be within specification.The dilator was able to move within the peel-away sheath with minimal resistance.A device history record (dhr) review was performed on the peel-away sheath and dilator and no relevant findings were identified.The ifu provides insertion techniques for the sheath/ dilator assembly and directs the user to pre-dilate the puncture site if necessary.It was not reported if this was done.(con't) other remarks: the report that the sheath body was deformed was confirmed by evaluation of the returned sample.The sheath body has raised/deformed material along the score line approximately 1.7cm from the distal tip.A dhr was performed and did not reveal any manufacturing related issues.Further investigation of this issue is being conducted under capa (b)(4).The failure investigation indicates that the probable cause is design related.

Event Description

The customer alleges that during insertion of the sheath/dilator over wire, the nurse felt something sharp approximately 2cm from the distal end of the sheath.Another device was used without issue.

• Brand Name: ARROW PI PICC: 2-L 5FR X 50CM W/ 80CM HYDRO
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6538153
• MDR Text Key: 74210393
• Report Number: 3003737899-2017-00040
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/18/2017

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: 12/31/2017
• Device Catalogue Number: PR-35052-HPHNM
• Device Lot Number: 13F16A0088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2017
• Initial Date FDA Received: 05/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2016
• 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