MAUDE Adverse Event Report: COVIDIEN SPIDER FX; CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE

Catalog Number SPD2-050-320

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician was using a spider fx as an embolic protection device in the distal left common carotid artery.The target lesion was described as 80% stenosis with little calcification and the vessel was observed to exhibit no tortuosity.Artery diameter and lesion length were reported to be 4.5mm & 30mm, respectively.An 8f non-medtronic long sheath and a 0.014x300 non-medtronic guidewire were used for the procedure.The lesion was pre-dilated.The ifu was followed during preparation, procedure and post procedure.It was reported that after opening the filter, the wire separated from the filter.It took a long time to close the filter in order to complete the procedure.The patient experienced a spasm during the procedure but then recovered.

Manufacturer Narrative

Image review two images received from the customer.The images show the horseshoe crimp was detached and was observed outside of the filter assembly.The device was returned to analysis lab for additional analysis.Device evaluation: the catheter was returned with the filter observed within the recovery end of the dual ended delivery catheter.Visual inspection of the spiderfx filter reveal one of horseshoe crimp sleeve was detached and observed outside of the filter assembly.The green delivery catheter was inspected and did not observe damage to the green shaft or the white distal tip.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: minimal resistance was experienced during advancement of the delivery system.There was no difficulty experienced during placement of the embolic protection catheter.Issues were experienced when removing the device from the patient.The wire separated in the patient¿s vessel but was removed.The detached wire and the filter were directed into the catheter and retrieved under some resistance.The patient had a stent implanted and was treated with a balloon.The patient is reported to be doing well.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPIDER FX
• Type of Device: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8443322
• MDR Text Key: 139553621
• Report Number: 2183870-2019-00145
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063204
• 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: 06/24/2019

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
• Device Expiration Date: 11/29/2020
• Device Catalogue Number: SPD2-050-320
• Device Lot Number: A747469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 05/10/2019; 06/14/2019
• Supplement Dates FDA Received: 05/08/2019; 06/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2018
• 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: 63 YR