MAUDE Adverse Event Report: ARROW INTERNATIONAL INC SPRING WIRE GUIDE COMPONENT; SPRING WIRE GUIDE PRODUCTS

Catalog Number AW-04435

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2014

Event Type  malfunction  

Event Description

It was reported that this incident occurred in the ed during insertion.There was difficulty reported with the swg unraveling (see mdr 1036844-2013-00087) and the dilator "peeling back" (see mdr 1036844-2014-00088).The physician alleged that they also have used cdc-45854-xp1a kits with aw-04435 spring wire guides.The physicians claim that the dilator is kinking the aw-04435 swg during insertion.There was no reported delay, death, or complication to the patient as a result of this issue.The device was removed and replaced to perform the procedure successfully.

Manufacturer Narrative

(b)(4).

• Brand Name: SPRING WIRE GUIDE COMPONENT
• Type of Device: SPRING WIRE GUIDE PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE MEXICO, S.A. DE C.V.; ave washington 3701; chihuahua 3120 0; MX 31200
• Manufacturer Contact: jody cadd, sr specialist ; 2400 bernville rd; reading, PA ; 6103780131
• MDR Report Key: 3915459
• MDR Text Key: 4488561
• Report Number: 9680794-2014-00058
• Device Sequence Number: 1
• Product Code: LFJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K895417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2014

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 Catalogue Number: AW-04435
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2014
• Initial Date FDA Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: No
• 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