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

Model Number 104-4770

Device Problems Burst Container or Vessel (1074); Material Deformation (2976)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

Medtronic received a report that the hyperform balloon was found to be damaged during extracorporeal inflating.No patient symptoms or further complications were reported as a result of this event.Additional information was received stating that the balloon was prepared as indicated in the instructions for use (ifu).The procedure was completed by replacing with another balloon.The procedure that was being performed was a balloon-assisted coil embolization.Leakage was discovered when the balloon was inflated during the system preparation in vitro.The cause of the damage was the balloon was damaged.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Product analysis: as found condition: the hyperform balloon catheter was returned for analysis within a shipping box; within a sealed biohazard pouch; within an opened hyperform balloon catheter inner pouch and within a dispenser track.Damage location details: no damages were found with the catheter hub.The catheter body was found to be damaged (stretched) at ~3.7cm from the distal end.No damages were found with the distal tip.No other anomalies were observed.Testing/analysis: the balloon lumen was flushed, and water exited the distal tip.An attempt to inflate the balloon was made with an in-house guidewire.The balloon was able to maintain inflation.No leaks were observed.No other anomalies were observed.Conclusion: based on the device analysis and the reported information, the customer¿s reports of ¿catheter kink/damage¿ was confirmed as the catheter body was returned damaged (stretched).Catheter damage can occur during packaging or while removing the catheter from the packaging, if either the catheter or guidewire is advanced or retrieved against resistance or due to incompatible devices.The model and lot numbers for the device used for the event was not returned.Therefore, the condition of the device could not be assessed.Since the device was not returned, an analysis could not be performed.Therefore, ¿incompatible devices¿ could not be ruled out as a potential cause.The root cause for the reported event could not be determined.Based on the device analysis and reported information, the customer¿s ¿balloon rupture during set up¿ report could not be confirmed as no issues were encountered inflating the hyperform balloon.Regarding the damage found with the hyperform catheter body (stretching), damage can occur if either the catheter or guidewire is advanced or retrieved against resistance.However, the cause for the damage could not be determined.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18961229
• MDR Text Key: 339050819
• Report Number: 2029214-2024-00489
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00763000294328
• UDI-Public: 00763000294328
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• 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: B448253
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2024
• Date Device Manufactured: 09/19/2022
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 79 KG