MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number AB35W06040080

Device Problems Burst Container or Vessel (1074); Fracture (1260); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem Rupture (2208)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician intended to use an evercross pta balloon with a 6fr sheath and 0.035 non-medtronic wire during treatment of a fibrous lesion in a proximal right upper arm fistula graft.Vessel diameter reported as 6mm.Lesion exhibited 90% stenosis.Slight tortuosity reported.Ifu was followed.No packaging issues noted prior to use.No issues noted when removing the device from the packaging.The device was prepped without issue.The device was not passed through a previously deployed stent.Resistance was encountered during advancement, but no excessive force was used.An inflation device was used with 1:3, contrast: saline mix for balloon inflation.It is reported that a circumferential/radial balloon burst occurred during first inflation at pressure of 14atm.The balloon remained on the wire.The sheath was upsized to 9fr and a snare was advanced down beside existing wire and snare end of wire and pull everything out together.It is believed that the staples from placement of synthetic graft may have been what ruptured the balloon.Slight resistance was felt while trying to remove balloon after rupture.Gentle pressure was applied as resistance is expected with a ruptured balloon.Once the balloon was removed it was discovered that the catheter had fractured and that the distal segment was still in the patient and could be seen under fluoroscopic imaging.A non-medtronic pta balloon was used which also ruptured and ruptured the vessel.A non-medtronic stent was then used to cover the ruptured segment.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: the fractured segment of the evercross catheter was removed using a snare.All fragments of the evercross balloon were removed from the patient.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: the customer returned three images for review.Two of the returned images were cine and one was a photograph.Review of the first cine image show the balloon expanded within the vessel with a guidewire loaded.A twist in the balloon is near the median-distal end of the balloon chamber.It was also noted that an object surrounded the proximal segment of the balloon; however due to the quality and clarity of the cine image it is not possible to positively identify what is surrounding the proximal segment of the balloon twist.The second cine image was reviewed.The catheter and two marker bands were identified.A snare was also identified; the snare was distal to the marker bands.Two sternal wires were noted to the left of the identified snare.Due to the quality and clarity of the cine image the device balloon and reported fracture could not be identified.The third image was reviewed.The returned image was a photograph of the proximal segment of the fractured balloon and catheter.The distal segment was not included in the photograph.A radial fracture of the balloon was noted.It was also noted that the catheter fractured proximal to the marker bands.Biological debris was noted on the balloon and catheter.The returned image was consistent with the reported event and returned device.Product analysis: the evercross pta catheter was returned to the medtronic investigation lab (plymouth) for review.The evercross pta catheter was returned within a sealed biohazard bag.No ancillary devices were returned with the catheter.The device was removed from the returned packaging for review.During visual analysis it was noted the device was returned in two segments, both segments were evaluated.The distal segment showed the distal marker band intact.A radial tear was noted in the median-distal portion of the balloon chamber.The blue catheter fractured proximal to the marker bands.The distal segment showed the marker bands intact.The balloon chamber material was folded/bunched up in an accordion fashion, biological debris prevented the balloon from being unfolded.Microscopic examination of the balloon could not confirm the presence of the proximal bond.The segment was submerged in water to remove the biological debris.After the removal of the biological debris the distal balloon chamber was able to be unfolded.Microscopic examination confirmed the presence of the distal bond remained intact.Examination of the of the fracture face of the distal segment of the catheter revealed the fracture was straight and appeared to be caused by a sharp object.Microscopic examination of the proximal segment revealed the proximal bond remained intact.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERCROSS 035
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 9327539
• MDR Text Key: 168598841
• Report Number: 2183870-2019-00542
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000184360
• UDI-Public: 00763000184360
• Combination Product (y/n): N
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/10/2020

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: 08/25/2022
• Device Model Number: AB35W06040080
• Device Catalogue Number: AB35W06040080
• Device Lot Number: A888211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 11/15/2019; 11/19/2019; 02/07/2020
• Supplement Dates FDA Received: 11/18/2019; 11/20/2019; 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR