MAUDE Adverse Event Report: MEDTRONIC, INC TAIGA 6F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Catalog Number TA6JR40

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Death (1802); Device Embedded In Tissue or Plaque (3165)

Event Date 04/07/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

The patient was being treated for acute myocardial infarction by pci.This was an urgent case.The lesion was situated in the rca and had 99% stenosis, severe calcification and moderate tortuosity.A radial approach was used.During the case the physician used a taiga guide catheter.No damage was noted to the catheter packaging.The device was removed from packaging, inspected and prepped per ifu with no issues noted.Since the patient was advanced age and had severe calcification, the procedure was a complicated case.The physician manipulated a guideliner and had difficulty implanting the stent.No resistance was encountered when advancing the guide catheter.Backup force of the reported jr40 guiding catheter was insufficient.Under cine images, the jr 40 shape became "al" rather than "jr" and the tip was crushed.However, the reported guiding catheter was not replaced and the procedure was continued.After the procedure was completed, it was noted that the tip of the guiding catheter was partly broken.It was unknown if the broken tip remained in the coronary artery.No check was made by fluoroscopy.Nobody checked if there was the broken tip around the surgical bed/operating table.No injury reported to the patient.

Manufacturer Narrative

No adjunctive therapy was provided.At an unknown date the patient died, the cause of the sudden death is unknown.Patient history includes heart failure.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

Product analysis:the distal white soft tip is torn and missing part of the tip from the distal end of the catheter.There is no other visible damage to the catheter.The tip is torn away at the distal edge of the sleeve.Approx.2mm x 2mm of the white soft tip material is missing and not returned, reportedly it is unknown if the material is in the patient or lost on the surgical bed.The tip material at the separation point is jagged there is no indication of a manufacturing bond failure.Sem results: the catheter did not exhibit any discoloration, splits or embrittlement on the soft tip.When the soft tip material was gently prodded with tweezers the material was easily flexed and recovered.There was evidence of significant scuffing with braid exposure in the light blue segment area on the inside radius of the curved section.4 photos received from the account matched device returned for analysis.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

Corrected information: sex.

Manufacturer Narrative

The physician does not believe that part of the taiga tip remained in the coronary artery because no delayed flow was observed by angiography.The physician believes that the patient¿s death, which occurred after being discharged from the hospital had no causal relationship with the broken tip.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TAIGA 6F GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6556801
• MDR Text Key: 74831843
• Report Number: 1220452-2017-00038
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2018
• Device Catalogue Number: TA6JR40
• Device Lot Number: 0008418570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2016
• 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 Outcome(s): Death
• Patient Age: 85 YR