MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PI CVC KIT: 3-L 7 FR X 20 CM AGB; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CDC-45703-XP1A

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No sample will be returned for evaluation.Information was received via voluntary sus report# mw5058202.

Event Description

It was reported that the anesthesiologist was placing a multi-lumen cvc kit in the patient and the outside layer of the guidewire became uncoiled and unattached from the underlying wire.As a result, everything was removed from the patient and a second kit was placed successfully.There was no delay in treatment and no patient death or complications reported.

Manufacturer Narrative

(b)(4) the reported event was confirmed through examination of a returned product sample.The customer returned a guidewire that was kinked and unraveled at the proximal end.Microscopic examination revealed that the core wire was broken adjacent to the weld.No pieces appeared to be missing.The device history records for the guide wire and catheter were reviewed with no relevant findings.The provided instructions describe suggested techniques to minimize the likelihood of guidewire damage during use and caution that withdrawing the guidewire against the needle bevel or use of excessive force during removal could damage or break the wire.Based on the observed damage and reported information, operational context caused or contributed to this event.No further action will be taken.

• Brand Name: PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: ARROWG+ARD CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5323309
• MDR Text Key: 34918690
• Report Number: 1036844-2015-00599
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2015

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: 02/28/2017
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 23F15F0834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2015
• 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