MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SUPPORT GUIDECATHETER; CATHETER, PERCUTANEOUS

Model Number RFX058-115-08

Device Problems Inadequacy of Device Shape and/or Size (1583); Packaging Problem (3007)

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

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received report that upon opening the package, the navien catheter was noted to have the coating part of the tip peeled off.A new support catheter was used to treat the patient.There are no images available.At the time of opening, the device was in a state of being covered by the packaging of about 1cm which was curled.The navien was damaged.

Manufacturer Narrative

The navien catheter was returned for analysis.The navien length was measured and was within specification.Upon visual inspection, no issues or irregularities were found with the navien catheter hub.No bends or kinks were found with the navien catheter body.The distal of the navien heat shrink tubing was found to be peeling.The navien distal tip was found to be damaged/deformed.No other anomalies were observed.This event is still under investigation.A supplemental report will be submitted when the investigation is complete.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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

The navien total length was measured to be ~122.6cm (reference : 123.0cm) and the useable length was measured to be ~116.0cm which is within specification (specification: 115cm ± 3cm).Upon visual inspection, no issues or irregularities were found with the navien catheter hub.No bends or kinks were found with the navien catheter body.The distal ~2.3cm of the navien heat shrink tubing was found to be peeling.The navien distal tip was found to be damaged/deformed.No other anomalies were observed.The navien catheter was returned for analysis.The distal navien heat shrink tubing was found to be peeling and the distal tip was found to be damaged/deformed.Based on the reported information and device analysis, the customer¿s report of ¿uneven/inadequate coating¿ was confirmed.The investigation determined that this event should be escalated for formal investigation.D00032861 - navien distal jacket peeling has been opened to investigate cause for this event.Based on the formal investigation conducted inadequate amount of activator during flexobond formulation and mixing is the possible root cause of distal jacket delamination, followed by handling damage by production at the packaging step during loading of the dispenser coil.Following inadequate amount of flexobond formulation and mixing, it is possible that the distal jacket was damaged by physicians during removal or preparation of catheter during normal operation.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: SUPPORT GUIDECATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8169170
• MDR Text Key: 130498007
• Report Number: 2029214-2018-01073
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00847536017795
• UDI-Public: 00847536017795
• Combination Product (y/n): N
• PMA/PMN Number: K110055
• 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: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2020
• Device Model Number: RFX058-115-08
• Device Catalogue Number: RFX058-115-08
• Device Lot Number: A579931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1