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

Model Number	AB14W030040150
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the nanocross elite was returned inside a biohazard bag with a nanocross elite device sticker attached which indicated lot a612711.No ancillary devices were included.The nanocross elite was inspected and found traces of dried blood on the exterior of the balloon.No damages or anomalies were observed to the balloon segment, catheter shaft, or manifold assembly.The strain relief was removed from the manifold assembly and found no damages to the catheter shaft.The working length of the nanocross elite measured to approximately 150cm.The distal tip of the catheter shaft was inspected under microscope and found no damages.A 0.014" guidewire from the lab was front-loaded the catheter and encountered resistance after approximately 8cm of the gw was loaded.The guidewire was back-loaded through the manifold and the gw was able to exit out from the distal tip of the catheter.It should be noted biologics were noted on the tip of the gw after loading through the lumen of the catheter shaft.The gw was front-loaded a second time and inspected the area of encountered resistance under microscope and found tip of the gw was protruding out of a hole of the catheter gw lumen.The product labelling associated to lot a612711 indicates a 0.014 gw and a working length of the 150cm.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a nanocross pta balloon along with non-medtronic 6fr sheath and 0.014 guide wire during procedure to treat a slightly calcified plaque lesion in the distal posterior tibial artery with 95% stenosis.The vessel diameter and lesion length are 3mm and 20mm respectively.The vessel was little tortuous.The balloon was inflated using an inflation device.There was no damage noted to packaging.There was no issues noted when removing device from hoop/tray.The device was prepped per ifu with no issues identified.Removal difficulty occurred.It was reported it was difficult to remove the balloon following balloon inflation.Force was used during withdrawal.The balloon was safely removed off the wire.The device was fully deflated upon withdrawal attempt.Physician had to rewire lesion and balloon could not be flushed after it was removed.No vessel damage occurred.There was no patient injury reported.

• Brand Name: NANOCROSS 0.14 OTW PTA DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10183845
• Report Number: 2183870-2020-00188
• Device Sequence Number: 13680174
• Product Code: LIT
• UDI-Device Identifier: 00821684066409
• UDI-Public: 00821684066409
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K082854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2021
• Device Model Number: AB14W030040150
• Device Catalogue Number: AB14W030040150
• Device Lot Number: A612711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1