MAUDE Adverse Event Report: ARROW INTL., INC. CATH PKGD: PACING 5 FR 110CM 10MM SPACIN; TEMPORARY PACING CATHETER PRODUCTS

Catalog Number AI-07150

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2014

Event Type  malfunction  

Event Description

It was reported that the event occurred while in the cath lab.During insertion of an ai-07150, the user met with insertion difficulty when setting the stylet into the catheter; several attempts were made.As a result, the stylet was not used.The user inserted the catheter without the stylet.The procedure went on as planned.The returned stylet was broken due to the repeated insertion attempts.There was no report of patient death, complications, injury or medical/surgical intervention required.There was no delay or interruption in therapy noted.The patient outcome is one cause harm to the patient.Additional information received on july 09, 2014 confirmed that the patient outcome was no cause harm to the patient.The stylet got stuck when inserting into the catheter.They were able to successfully complete the procedure as planned.

Manufacturer Narrative

Complaint no (b)(4).

• Brand Name: CATH PKGD: PACING 5 FR 110CM 10MM SPACIN
• Type of Device: TEMPORARY PACING CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 2 berry dr.; mt. holly NJ 08060
• Manufacturer Contact: kathryn myers, associate ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4120900
• MDR Text Key: 4794753
• Report Number: 2242445-2014-00008
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K960479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AI-07150
• Device Lot Number: MF3033262
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2013
• 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