MAUDE Adverse Event Report: MEDTRONIC, INC TAIGA GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number UNK-CV-DAN-TAIGA

Device Problems Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis (b)(4): device deconminated in cidex-opa and tergazyme.Device returned coiled in plastic bag.Two non mdt intro ducers were also returned.If information is provided in the future, a supplemental report will be issued.

Event Description

A 6f taiga guide catheter was used during a procedure to treat a non-tortuous, severely calcified lesion with 75-90% stenosis in the left anterior descending (lad) artery.The device was removed from packaging per ifu with no issues.The device was inspected with no issues noted.The device was prepped per ifu with no issues.A 6f non-mdt sheath and a non-mdt guide wire were used.No resistance was noted when advancing the device and excessive force was not used.The taiga was attempted to be positioned but difficulties were noted so the catheter was exchanged.It was reported that an attempt was made to replace the taiga jl35 product with another shaped catheter and the taiga failed to be removed via the non-medtronic sheath.The taiga got caught on the sheath and could not be removed so both devices were removed together.Resistance was noted at the tip of the non-medtronic sheath when the taiga device was at tempted to be removed.It was reported that a second taiga il40 was also inserted into the patients body and a similar issue occurred.It was also reported that the catheter kinked.The procedure was then completed using another catheter.It was indicated by the physician that this was not a sheath or guide product issue but a problem with operation method or patients vasculature.The physician suspected that it might not be due to the guiding but due to a sheath defect.The patient was reported to be alive with no injury.

Manufacturer Narrative

Product analysis: device returned coiled in plastic bag.Two non mdt introducers were also returned.One 6f taiga catheter and two non mdt introducer sheaths were returned for analysis.The guidewire was not returned.The catheter was not loaded into either introducer sheath upon return.No deformation was noted to one non mdt introducer sheath.The catheter could be loaded into the sheath and resistance was noted at the catheter kink sites.The catheter could be removed from the sheath.The od of the sheath measured 0.108¿.Kinks were noted on the second non mdt sheath.The catheter could be loaded into the sheath and resistance was noted at the kink sites.The catheter could be removed from the sheath.The od of the sheath measured 0.097¿.No deformation was noted to the tip of either introducer sheath.Kinks were noted on the distal shaft of the taiga catheter approx.69cm and 70cm from the strain relief.Slight deformation was noted at the bond between the sleeve and primary segment.Wire braid could be seen.The od of the catheter measured 0.083¿ meeting specification of 0.082¿ +/- 0.001¿.The id measured 0.072¿ meeting specification of 0.072¿ +/- 0.001¿.No other deformation noted.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: TAIGA GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 10256572
• MDR Text Key: 200048988
• Report Number: 1220452-2020-00056
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K083422
• 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: 07/20/2020

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: UNK-CV-DAN-TAIGA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 07/02/2020
• Supplement Dates FDA Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR