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

Catalog Number AB14W060200150

Device Problems Deflation Problem (1149); Material Puncture/Hole (1504); Detachment of Device or Device Component (2907)

Patient Problems Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)

Event Date 01/21/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Pertains to a nanocross elite device: during aortogram with right leg runoff and subsequent right popliteal artery thromboembolectomy.Disruption of an 0.146 x 200 angioplasty balloon occurred with inability to remove the distal segment which was retained in the severely diseased and essentially previously occluded distal superficial femoral artery and above-knee popliteal artery.Quick cross catheter was advanced into popliteal artery.Thirty five guidewire exchanged out with a 0.14 wire.A 4-200 0.14 balloon was used to further angioplasty the vessel.Following completion bolus angiography revealed superficial femoral artery patent, diffusely diseased with irregularities and evidence of focal areas of dissection.A 0.146x200 balloon was used to angioplasty the popliteal artery above the knee as well as distal superficial femoral artery - during which the balloon was noted to puncture.Balloon could not be deflated distally.It gradually slated but could not be removed.Further traction on the balloon catheter resulted in separation of the distal two thirds of the balloon catheter.Balloon remained in patient until two days later when patient underwent right popliteal artery endarterectomy to remove retained balloon.No further patient injury reported for this event.

Manufacturer Narrative

Device evaluation: the nanocross elite was returned.The separated distal end of the nanocross elite catheter was placed inside a separate biohazard pouch.It was noted a 0.014" guidewire was loaded the proximal segment of the nanocross elite catheter.The distal segment was analyzed initially.The balloon showed dried biological material within the balloon.The balloon was shifted towards the distal tip of the catheter.The length of the balloon was 18cm and the length of the blue inner was approximately 50cm.The proximal end of the expanded balloon showed a radial burst.The blue inner was stretched out and the fracture face of the inner was ductile in nature.The distal end of the balloon catheter, proximal end of the balloon burst, and the proximal fracture face of the inner was inspected under microscope.The proximal segment of the nanocross elite was analyzed.Approximately 33 cm of the guidewire was observed outside of the distal end of the blue inner of the nanocross elite.The length of the blue inner stretched out past the clear balloon burst was approximately 61.5cm.The working length measured from the distal end of the blue inner was 193cm.The distal edge of the blue inner showed a ductile fracture face.The balloon was inspected and found evidence of a radial burst.It should be noted the manifold showed dried blood within the balloon inflation port.It should be the product labeling associated to lot a701011 indicates a working length of 150cm.Image review the customer provided a cine image from the procedure.The cine was analyzed and appears to show the balloon expanded within the vessel was a guidewire loaded.The expanded balloon shows a space/gap at the balloon segment.The image does not conclusively identify a fracture, but does indicate difficult was experienced while the balloon was inflated.It is unknown if the balloon may have been twisted the area of the space/gap.Medtronic is submitting this report to comply with fda reporting regulations under 21 if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information received a 4-200 0.14 evercross balloon was used to further angioplasty the vessel.A balloon burst was reported.An evercross 4x150 was used to complete the procedure.A 6x200 nanocross elite balloon was used to angioplasty the popliteal artery above the knee as well as distal superficial femoral artery.No resistance or excessive force was used.A gooseneck snare was used in an attempt to remove the components without success.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8309641
• MDR Text Key: 135146092
• Report Number: 2183870-2019-00059
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2021
• Device Catalogue Number: AB14W060200150
• Device Lot Number: A701011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 02/12/2019; 05/06/2019
• Supplement Dates FDA Received: 02/22/2019; 05/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 84