MAUDE Adverse Event Report: FUJI SYSTEMS CORPORATION CELLO BALLOON GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number 1610090

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

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

Event Date 12/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the balloon appeared to have burst during preparation, with it unable to inflate.The patient was undergoing ais treatment.It was noted that the patient's vessel tortuosity was normal.The devices were prepared and flushed as indicated per the ifu.There were no related patient symptoms.

Event Description

Additional information received indicated the physician did preparation for the cello one time, and the rupture was seen in the first preparation.The ruptured cello was not used in the procedure.

Manufacturer Narrative

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.

Manufacturer Narrative

H3: the cello balloon guide catheter (model: 1610090 lot: 5000033) was returned for analysis.The cello total length was measured to be ~100.2cm.The cello usable length was measured to be ~91.6cm.The balloon inflation port was found to be still attached.No damages were found with the main lumen hub.The balloon inflation port was removed for further visual inspection of the balloon lumen hub.The balloon lumen hub was found to be cracked.The cello balloon guide catheter body was found to be kinked at ~55.6cm and ~37.0cm from distal tip.Upon visual inspection, no issues were found with the distal tip or balloon.No other anomalies were observed.The cello balloon guide catheter was sent to fuji corp for further investigation.Per fuji investigation report, "we found the returned product had kinks at the positions of 371mm, 557mm, 600mm from the tip.No abnormality such as damage is found by investigating the appearance of the balloon.·to check the balloon condition, we inject water into the accessory of balloon hub (defined as the accessory below) after we connected to a syringe, we found the water leakage from the accessory and the balloon, and we could not inflate the balloon.·we found the crack on the connection part of the balloon hub.·we directly connected a syringe to the connection part of balloon hub and injected water, we found the water leakage from the crack.·we attempted to inject water into the balloon by holding the cracking part with a finger, we could inflate and deflate the balloon without any abnormal resistance although the leakage from the cracking part was found.At this moment, no leakage except from the hub was found.Based on the above results, even though the balloon rupture was not found, we confirmed the crack on the balloon hub.Presuming the cause for this event, the load was applied to the balloon hub when the accessory was removed during the priming, and a syringe or 3-say stop cocks was directly connected.We can consider this was the possibility that made damage on the balloon hub and unable to inject water into the balloon and became inflatable." 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): FUJI SYSTEMS CORPORATION; 200-2 aza ohira, odakura; nishigo, nishi shirakawa gun; fukushima-ken CA 961-8 061; JA 961-8061
• MDR Report Key: 11170411
• MDR Text Key: 226885795
• Report Number: 2029214-2021-00054
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• 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: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: 1610090
• Device Catalogue Number: 1610090
• Device Lot Number: 5000033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 82