MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CELLO BALLOON GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number 1610080

Device Problems Break (1069); Packaging Problem (3007)

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

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation; therefore, the event cause could not be determined.Correspondence has been sent out for the device.Once the device has been received and the investigation completed, a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that when pulling the package, the physician noticed the middle segment of the microcatheter was already broken inside the packaging.The procedure was completed with another device.There was no evidence of tampering of packaging.No patient injury was reported as a result of the event as it occurred outside of the patient.

Manufacturer Narrative

Device evaluation analysis found the cello catheter body was kinked ~71.0cm, 34.3cm, and 22.5cm from the distal tip.In addition, the cello balloon tip was found bent (kinked).Upon visual inspection, no issues or irregularities were found with the balloon.The cello catheter main lumen was flushed, water exited from the distal tip.The cello balloon was inflated and held inflation.Based on the analysis, the event could not be confirmed.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: CELLO BALLOON GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8711396
• MDR Text Key: 148428750
• Report Number: 2029214-2019-00582
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K120781
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: 1610080
• Device Lot Number: 5700056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1