MAUDE Adverse Event Report: MEDTRONIC, INC ANGIOGRAPHIC GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number 007042

Device Problem Flaked (1246)

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

Event Date 04/30/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a tavr procedure an attempt was made to use one angio guidewire to treat a non tortuous and non calcified lesion.The device was inspected with no issue noted.The device was prepped per ifu with no issues.The wire tip was not formed.Resistance was experienced during insertion.Excessive force was not used.It was reported that the wire kinked when in the patient.Damage was noted to the device post removal from the patient.When inserting the wire into the catheter it was noted that there was a grinding feeling and on removal it was noticed that a small amount of the colour on the wire had flaked off.The wire was replaced with another wire and the tavr case was continued without issue with no harm to the patient.The patient is alive with no injury.

Manufacturer Narrative

Product analysis one angiographic guidewire was received at medtronic for analysis.A kink was noted on the wire.The wire was wiped with a non-wovan gauze that was soaked in saline and green residue was transferred onto the gauze.The device was further reviewed by the vendor, the presence of a kink was confirmed.There was no evidence of flaking.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: ANGIOGRAPHIC GUIDE WIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 11929296
• MDR Text Key: 254331277
• Report Number: 9612164-2021-02158
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00643169856714
• UDI-Public: 00643169856714
• Combination Product (y/n): N
• PMA/PMN Number: K082873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

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 Model Number: 007042
• Device Catalogue Number: 007042
• Device Lot Number: GFFP0081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1