MAUDE Adverse Event Report: MEDTRONIC, INC INTRAKIT; INTRODUCER, CATHETER

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician used a launcher guide catheter and an intrakit transradial access kit during a procedure.There was no damage noted to the launcher packaging.The launcher device was not inspected.The diagnostic angiogram was performed without problems.The intrakit transradial sheath was put in without effort.The patient then needed an intervention.An attempt to advance the 6f launcher catheter through the intra kit 6f sheath was made without success.A lot of resistance was felt.The catheter went through the hub, but the catheter could not get past the tip of the sheath.The physician reported that the exit point of the sheath was not 6f to accommodate the 6f catheter.A sheath exchange was not done because the physician was scared that the patient could get radial artery spasm.The physician¿s concern over sheath exchange and radial artery spasm was not related to the intrakit sheath.The physician was concerned about radial spasm in general, not because it was an intrakit.A femoral approach was used to finish the procedure.The patient was impacted in that there was a puncture site in the patient's arm and groin.The procedure was also longer.The current status of the patient is unknown.

Manufacturer Narrative

Additional information: patient is fine and was fine at the time of the case as well.Correction: updated notified date is (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis summary: the devices exhibited blood stains indicating use or handling in a medical setting.The guide catheter was received with an s shape.Visual inspection of the catheter detected a kink on the shaft.The guide catheter measurements met specifications.The intrakit had no visual damage.The actual sheath od, sheath id at the tip and at the hub met specifications.During recreational testing an in-house 6f guide catheter was passed through the lumen of the returned introducer sheath resulting in some resistance but regardless of the noted resistance, the catheter advanced and exited the tip of the sheath.The outer diameter of the in-house sample was 0.0861¿ indicating a higher od compared with the returned guide catheter, the in-house catheter od was below maximum outer diameter.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTRAKIT
• Type of Device: INTRODUCER, CATHETER
• 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: 7251339
• MDR Text Key: 99349232
• Report Number: 1220452-2018-00011
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K162097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 02/23/2018; 03/29/2018
• Supplement Dates FDA Received: 03/22/2018; 04/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention