MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PICC SET: 2-LUMEN 4 FR X 19-1/2"; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number PR-05042

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received by the manufacturer, but the investigation is incomplete at the time of this report.

Event Description

The customer reports that during insertion, the dilator would only pass to 1 cm and then it bent/kinked.

Manufacturer Narrative

(b)(4).The customer returned one peel-away sheath/dilator assembly for evaluation.A visual exam was performed and it was observed that the assembly was curved near the sheath tip, the sheath body was accordion along one score line, and the dilator tip was pushed back.The sheath body was accordion from 9mm to 14mm from the distal tip with a small tear in the score line within the damaged area.Microscopic examination confirmed the sheath and dilator damage.This type of appearance can occur when the sheath body is pushed back toward the proximal end during insertion.The damaged area had white areas indicating the material was stressed after manufacture.The sheath body measured 4.016" in length, which met specification.The dilator protruded through the catheter 1.456", which also met specification.The inner diameter (id) of the sheath tip and the outside diameter (od) of the dilator body were found to be within specification.A device history record review was performed on the sheath/dilator assembly with no relevant findings.The instruction booklet provides insertion techniques for the sheath/dilator assembly.The ifu directs the user to enlarge the puncture site if necessary.It was not reported if a skin nick was made prior to insertion.The report that the sheath/dilator assembly would not advance and bent during insertion was confirmed through examination of the returned sample.The sheath exhibited white stressed areas and rippled material that is pushed back toward the proximal end.The ripples indicate that the sheath met resistance during insertion and it pushed the material back.Based on the appearance of the sheath and the report that it bent during insertion, it was determined that operational context caused or contributed to this event.

Event Description

The customer reports that during insertion, the dilator would only pass to 1 cm and then it bent/kinked.

• Brand Name: ARROW PICC SET: 2-LUMEN 4 FR X 19-1/2"
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: 6527222
• MDR Text Key: 74022244
• Report Number: 9680794-2017-00081
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

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: No Information
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: PR-05042
• Device Lot Number: 14F16L0303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2016
• 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
• Patient Age: 3 YR