MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 HYPERGLIDE; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number 104-4112

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/11/2021

Event Type  malfunction  

Event Description

Medtronic received a report that the balloon was inflated on the sterile table to ensure proper functioning.It was noticed the balloon was punctured.There was no consequence for the patient as a result of the event.Additional information received reported there was no knowledge of a balloon puncture, only that the balloon did not inflate during preparation.The catheter was not leaking any contrast or saline.Additional information received reported the balloon was punctured.The catheter wall was not punctured.

Manufacturer Narrative

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

Manufacturer Narrative

H3: the hyperglide occlusion balloon catheter was returned for analysis.There was no guidewire returned with the balloon catheter.No damages or irregularities were found with the hyperglide hub.No bends or kinks were found with the hyperglide catheter body.Upon visual inspection, no damages or irregularities were found with the hyperglide balloon distal tip.An in-house 0.010¿ mandrel was then advanced past the tip and the balloon was inflated.The balloon could not maintain inflation as it was found to be leaking proximal to the distal marker band.A hole in the balloon chronoprene tubing was found at the location of the leak.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿no/slow inflation during set up¿ was confirmed as a hole was found in balloon chronoprene tubing.However, the cause of the damage could not be determined.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.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: HYPERGLIDE
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13029360
• MDR Text Key: 286668685
• Report Number: 2029214-2021-01630
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K101570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2023
• Device Model Number: 104-4112
• Device Catalogue Number: 104-4112
• Device Lot Number: B122118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 01/20/2022
• Supplement Dates FDA Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2020
• 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 Age: 55 YR
• Patient Sex: Male