MAUDE Adverse Event Report: COVIDIEN LLC NANOCROSS 0.14 OTW PTA DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number AB14W030080150

Device Problem Occlusion Within Device (1423)

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

Event Date 09/29/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

After successfully inserting and inflating the nanocross balloon, there was a problem in deflating the balloon.Multiple unsuccessful attempts were made with the indeflator and a 10cc syringe to evacuate the contrast out of the balloon.The angiogram still showed that the balloon had contrast in it.At this time, the indeflator was set to 3 atm pressure.The balloon finally showed no contrast and was removed after this.Total inflation time turned out to be over 4 minutes.The procedure was finished by performing atherectomy and a drug-coated balloon inflation.There were no adverse consequences to the patient, and the patient was discharged on the same day without any complaints.The nanocross 0.014in otw pta dilatation catheter was received for evaluation.During investigation, a kink was noticed at approximately the balloon chamber's mid-point.Another kink in the guidewire lumen was also noted just proximal of the proximal balloon bond.The inflated balloon was examined under magnification, and a blockage was noted approximately 0.5cm proximal of the proximal balloon bond.The source of the blockage is unknown.

• Brand Name: NANOCROSS 0.14 OTW PTA DILATATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN LLC; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN LLC; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: mary haufek ; 4600 nathan lane north; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 5243399
• MDR Text Key: 32134685
• Report Number: 2183870-2015-07554
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• 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 Model Number: AB14W030080150
• Device Catalogue Number: AB14W030080150
• Device Lot Number: A051065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2015
• 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
• Patient Weight: 79