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

Catalog Number	SPD2-US-040-320
Medical Device Problem Codes	Kinked (1339); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	02/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the spiderfx embolic protection device was returned for evaluation.No ancillary devices or cine images from the procedure will be returned for evaluation.The spiderfx filter was received loaded within the green delivery end of the duel ended pouch.The ball weld of floppy distal tip protruded from distal end of the green delivery catheter.Attempts were made to advance the filter proximally and distally.The white distal tip of the green delivery catheter exhibited lateral compression.A series of kinks in the catheter were spaced from the primary wire port through the transparent section of the delivery catheter.The spiderfx was loosely coiled and placed in a tub of water overnight to dissolve water-soluble residue.The spiderfx was removed from the water and an attempt was made to advance the spiderfx filter in either direction.The filter advanced proximally but the green delivery catheter started to deform.The delivery catheter proximal to the filter was removed.The distal segment of the delivery catheter was advanced distally off the spider fx filter.The exposed spiderfx distal assembly exhibited several kinks.The floppy distal tip exhibited kinks and coil offsets in the distal coil.The flex connector within the spiderfx filter was kinked.The tapered capture wire was kinked.The directionality of the kinks caused the distal assembly to curve.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use spider fx embolic protection catheter and h1-ls directional atherectomy to aid in the treatment of a moderately calcified plaque lesion in the right proximal popliteal artery.The vessel was moderately tortuous.Both devices were prepped.The spider was prepped as per the ifu with no issues identified.The device was advanced with no issues over an.014 wire and was properly loaded.The vessel was pre and post dilated.It was reported the physician experienced difficulty retrieving the device back into the green delivery filter as it had flipped upside down during deployment.Force had been applied before the physician noted the flipped filter.The physician reported he pulled the spider wire back harder than normal while pushing the green catheter and it eventually popped back into the catheter.It was reported that a dissection occurred, and the physician wasn¿t comfortable hawking on a dissection.The physician performed orbital atherectomy, stenting and balloon angioplasty in the tibial arteries using non-medtronic devices to complete the procedure.There is no allegation against the hawkone device.

• Brand Name: SPIDER FX
• Common Device Name: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7309167
• Report Number: 2183870-2018-00122
• Device Sequence Number: 2378831
• Product Code: NTE
• UDI-Device Identifier: 00821684068328
• UDI-Public: 00821684068328
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2019
• Device Catalogue Number: SPD2-US-040-320
• Device Lot Number: A406833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention