MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 07/28/2014

Event Type  Injury  

Event Description

Information received by medtronic indicated that the user was unable to introduce the sheath into the vein of the patient at the groin access site.The sheath was replaced and the same issue occurred with the second sheath.The user reported that the interval between the introducer and the sheath was too big and that only the introducer could be inserted into the vein.The case was aborted; the patient was under general anesthesia for the procedure and did not receive any therapeutic treatment.Device 2 of 2, reference mfr report: 3002648230-2014-00136.

Manufacturer Narrative

The device has not yet been returned for evaluation.Results of evaluation of returned device will be submitted in a supplemental report.

Manufacturer Narrative

The returned device was visually inspected and functionally tested.The reported issue (unable to introduce sheath into vein of patient) could not be confirmed.The sheath passed the returned product inspection as per specification.Visual inspection showed that the shaft, sheath and dilator were intact with no apparent issues.Both the distal tip and dilator tip were intact, no fracture, breakage or kink were noticed.No teflon delamination was noticed at the tip of the shaft.The tip was atraumatic and with no sharp edges.The inner diameter of the tip was within specification and it provided a smooth transition to the dilator.The transition gap between the tip and the dilator was normal as seen in 4fc12 flexcath advance sheaths.Functional test of the sheaths showed that the deflection worked as per specification.Dilator could be snap-locked into the handle and it does not pull out from handle.This report will be recorded and trended.

Manufacturer Narrative

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

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland,qc H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland,qc H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: voula radiotis ; 16771 chemin ste-marie; kirkland,qc H9H 5-H3 ; CA H9H 5H3 ; 5146941212
• MDR Report Key: 4005073
• MDR Text Key: 4773940
• Report Number: 3002648230-2014-00137
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2015
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 81488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2014
• 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): Other
• Patient Age: 00058 YR