MAUDE Adverse Event Report: ARROW INTERNATIONAL INC.; PERIPHERALLY INSERTED CATHETER PRODU

Catalog Number ASK-35041-HMC

Device Problems Kinked (1339); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the procedure was being performed in interventional radiology.During insertion, the sheath began to peel back and kink about 1/3 to 1/2 the distance proximal to the distal tip.Follow up information states another arrow sheath was used to complete the procedure.There was no patient death or complications reported.

Manufacturer Narrative

(b)(4).Device evaluation: the report that the sheath began to peel back and kink was confirmed.One peel-away sheath dilator assembly was returned.Microscopic examination found that one side of the sheath was split / deformed between 8 and 25 mm from catheter tip.In addition there was one accordion fold in the sheath located 42 mm from the tip.The sheath body measured 3.94" in length which met specification of 3.937 - 4.063" per the sheath graphic.The dilator protruded through the sheath 1.61", which meets the specification of 1.312 - 1.688" per the dilator sheath assembly graphic.The inner diameter (id) of the sheath tip measured 0.0585" using pin gauges, which met specification of 0.0585 - 0.0595" per the sheath graphic r-05041-008b, rev.3.The outside diameter of the dilator body measured 0.0590" using ring gauges, which met specification of 0.0565 - 0.0595" per the dilator graphic.This type of damage can occur when the sheath body is pushed back toward the proximal end.All the damaged areas had white areas indicating the material was stressed after manufacture.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 other remarks: nick was made prior to insertion.A device history record review was performed and did not reveal any manufacturing related issues.Based on the appearance of the sheath and the report that it became damaged during insertion, operational context caused or contributed to this event.No further action will be taken.

• Type of Device: PERIPHERALLY INSERTED CATHETER PRODU
• 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: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 6050546
• MDR Text Key: 58194925
• Report Number: 3003737899-2016-00046
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASK-35041-HMC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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