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

Catalog Number AB35W05060080

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/24/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician attempted to use an evercross pta balloon catheter to treat a patient¿s superficial femoral artery.The procedure was performed according to the ifu.It is reported that the balloon burst when physician tried to inflate.There was no injury to the patient.

Manufacturer Narrative

Updated section e additional information: the balloon did not fragment.There was no difficult removing the balloon from the patient.No intervention was required.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.

Manufacturer Narrative

Product analysis: the evercross pta balloon catheter was received sealed within a plastic biohazard pouch, within a sealed hospital facility sterilization pouch, and loaded within a transportation hoop.No ancillary devices nor procedural photographs were received for analysis.It was noted that sealed hospital facility sterilized pouch indicated that the catheter was 4 x 100mm, (photo 4).The y-manifold printed strain relief indicates that the balloon is 4 x 100mm.Per the customer experience report the product identification code is ab35w05060080; indicating that the balloon catheter is an evercross pta balloon catheter with a 5mm x 60mm balloon on an 80cm shaft.The received device is not consistent with the reported device.The received evercross 4mm x 100mm balloon catheter was received with the balloon protector sheath over the balloon chamber.The balloon protector sheath was able to be removed with ease.The balloon chamber material is tightly wrapped and winged; within a pre-inflation profile.A 10cc water filled syringe was attached to the proximal hub luer lock and the guidewire lumen was flushed: a clear steady stream of fluid was observed exiting the distal tip of the catheter.A 0.035¿ compatible guidewire was loaded with ease through the distal tip of the catheter and navigated out the proximal hub luer lock with ease.A 10cc water filled syringe was attached to the inflation lumen luer lock of the y-manifold.A vacuum could be pulled and maintained indicating no communication between the inflation pathway and the environment.The water filled syringe was pressurized and the balloon chamber could be inflated; no leaks were noted.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: 9947932
• MDR Text Key: 194540754
• Report Number: 2183870-2020-00108
• Device Sequence Number: 1
• Product Code: LIT
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AB35W05060080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1