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

Model Number 104-4770

Device Problem Inflation Problem (1310)

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

Event Type  malfunction  

Manufacturer Narrative

H3: product analysis of 104-4770, lotno:b566209 found no damages with the hyperform hub.The catheter body was found stretching laterally and ruptured at ~151.5cm from the proximal end.The catheter body is found stretched lengthwise between ~151.5cm from the proximal end and ~7.5cm from the distal end.No damages or irregularities were found with the balloon subassembly.There was no evidence that the balloon has been previously inflated.The balloon catheter could not be inflated as the catheter was found ruptured proximal to the balloon subassembly.Based on the device analysis and reported information, the customer¿s reports of ¿no inflation during procedure¿ was confirmed.It is likely the catheter became stretched lengthwise, which prevented the contrast from entering the balloon subassembly to inflate.The catheter was found stretched laterally and ruptured.It is likely the rupture happened due to the contrast solution being trapped proximal to the catheter damage, causing the catheter to expand laterally and ultimately causing the rupture.Possible causes for catheter stretching are patient vessel tortuosity or user advances the guidewire against high resistance.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.

Event Description

Medtronic received a report that after preparing the hyperform balloon, and inserted it into the patient, the balloon does not inflate as expected.No patient symptoms or further complications were reported as a result of this event.Additional information received reported there was not extensive guidewire manipulation.A synchro guidewire was used.The guidewire tip was reasonably advanced out of the catheter tip during inflation and deflation.The physician did not shape the guidewire tip.50:50 contrast was used.A steady injection rate was used.A syringe steady injection was used to deflate the balloon.After multiple attempts the catheter and guidewire were removed and inspected.No clot was found.No blood entered the catheter lumen.No contrast was observed leaking during inflation attempt.There were no kinks on the catheter during use.

• Brand Name: HYPERFORM
• 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: 18491685
• MDR Text Key: 332643468
• Report Number: 2029214-2024-00089
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00763000294328
• UDI-Public: 00763000294328
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: Physician
• Type of Report: Initial
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 104-4770
• Device Catalogue Number: 104-4770
• Device Lot Number: B566209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2023
• 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