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

Model Number AB14W020040150

Device Problems Burst Container or Vessel (1074); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2016

Event Type  malfunction  

Event Description

Amphirion deep pta balloon was deployed in mid-distal peroneal artery with stenosis (calcification) present and inflated to 7atm (nominal) on first inflation at lesion.However, the balloon was unable to maintain its constant pressure as shown on the inflation device where the pressure kept dropping.A second inflation attempt was done but likewise, the balloon was unable to maintain at nominal pressure.Physician suspected that there could be a leak in the balloon.As there was still a focal calcified stenosis present in the distal peroneal artery after the amphirion deep pta balloon inflations, physician decided to deploy a nanocross pta balloon for focal treatment and inflated it to 10atm (nominal) on first inflation at lesion.However, the balloon was unable to maintain its constant pressure as shown on the inflation device where the pressure kept dropping.A second inflation attempt was done but likewise, the balloon was unable to maintain at nominal pressure.Physician suspected that there could be a leak in the balloon as well.The lesion was moderately calcified which exhibited 80% - 85% stenosis, vessel was non-tortuous.The lesion diameter is 2.0mm and lesion length 120mm.There was no injury to patient.Lesion was treated with a competitor product (ie.Abbott¿s armada 14 pta balloon).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: the nanocross device was returned inside a clear re-sealable bag.The nanocross was inspected and noted dried white residue within the balloon segment.Within the balloon segment buckling of the catheter was noted approximately 0.75 cm from the tip.A kink to the catheter shaft was noted approximately 47m from the tip.The balloon was inspected under microscope and was unable to identify any holes or tears to the balloon material.A guidewire could not be loaded due to the buckling noted to the catheter within the balloon segment.An inflation device filled with water was able to inflate the balloon and hold pressure at 12 atm for 5 minutes.No leaks were detected.The nanocross was next administered with 18 atm pressure for 5 minutes and no leaks detected.The inflated catheter was submerged and soaked in water for 24 hours.No leak from the balloon was detected, however the dried residue dissolved.The buc kling proximal to the distal marker band was more visible/clear.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NANOCROSS 0.14 OTW PTA DILATATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6292159
• MDR Text Key: 66217172
• Report Number: 2183870-2017-00045
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K132777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2017
• Device Model Number: AB14W020040150
• Device Catalogue Number: AB14W020040150
• Device Lot Number: A117900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 75