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

Model Number	AB14W040210150
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the nanocross pta dilatation catheter was received within a sealed large white envelope, within a sealed tyvek pouch, within a sealed plastic biohazard pouch, within its opened labeled shelf carton, and loosely coiled within its opened label pouch.No ancillary devices nor procedural images were received for analysis.The nanocross catheter was received with the balloon chamber in a post-inflated profile, (e.G.Not tightly wrapped and winged), the balloon chamber was separated at the proximal cone, and the balloon chamber inner guidewire was stretched/necked down.The balloon chamber was separated from the inflation lumen approximately 127.5cm from the y-manifold distal tip.The proximal end of the balloon chamber is approximately 165.4 mm.All the marker bands are accounted for.The proximal fracture face exhibits necking down at the proximal balloon bond and torsional radial separation.The distal fracture face exhibits radial separation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a nanocross pta balloon during treatment of a calcified cto (chronic total occlusion-100%) in the patient¿s mid peroneal artery.Severe vessel calcification is reported.No damage noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.The device was not passed through a previously deployed stent.No resistance was noted during advancement of the device.A non-medtronic inflation device was used for balloon inflation.It is reported during an attempt to remove the balloon from the patient, the catheter it was on stretched out and the balloon stayed in the vessel (but still attached to catheter).The physician was able to push the catheter back in and remove the balloon over the catheter without any residual effects to the patient.There were no detached components.There was no deflation difficulties noted.The balloon was fully deflated prior to removal attempt.No vessel damage was noted.No 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: 10703249
• Report Number: 2183870-2020-00339
• Device Sequence Number: 11541110
• Product Code: LIT
• UDI-Device Identifier: 00763000110208
• UDI-Public: 00763000110208
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/20/2020

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: 06/12/2023
• Device Model Number: AB14W040210150
• Device Catalogue Number: AB14W040210150
• Device Lot Number: B039804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 67