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

Model Number	SPD2-US-070-320
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Image review: two images were returned for review.The first was a photograph of the distal tip of the hawkone and was taken outside of the patient.Inspection of the photograph revealed that the distal housing, including the inner laser drilled coils and rotating distal tip, had detached and separated from the device at the proximal end of the housing where the coils initiate, distal the anchor pockets.The housing and rotating distal tip were not included in the photograph.In the photograph, the drive shaft of the device was advanced.It was observed that several of the inner laser drilled coils were wrapped around the drive shaft.The second image returned was a cine of the device while in patient use.It was noted that the device had passed through an area with a high arch, which appeared to be 90-degree bend.The distal housing, including the rotating distal tip were noted in the cine.The cutter and flush windows were observed.The detachment of the distal housing assembly could not be identified in the cine.A guide wire device was also identified in the cine.Based on the reported event and returned devices, the guide wire is presumed to be the spider fx device.The distal end of the spider fx device appeared to be around the distal rotating tip of the hawkone.Product analysis the device was returned to medtronic investigation lab for evaluation.The hawkone housing assembly, including the inner laser drilled coils and the rotating distal tip, were returned in a separate, smaller plastic bag, along with the spider fx device.Spider fx ancillary device was also returned along with the hawkone device.Two images were also returned for review.The spider fx device and hawkone were removed from the smaller bag for investigation.Upon removal it was observed that the spider fx remained loaded through the distal rotating tip of the hawkone.A blood-like substance and biological debris was noted throughout the housing and the spider fx device.Inspection of the spider fx device revealed multiple bends and kinks in the capture wire and the distal wire.During analysis, it was observed that the distal coiled tip was detached and separated from the distal wire.The coiled tip was not returned for evaluation.A bend was observed in the distal wire approximately 0.8cm proximal to the distal tip.A kink was also observed in the wire running through the filter assembly and was located approximately 2.9cm proximal to the distal tip.Proximal to the filter assembly, the capture wire was bent in an ¿s¿ shaped curve with multiple bends along the wire.The bends were located approximately 5.3 and 7.8cm proximal to the distal tip.A twisted section of the wire and a loop was observed approximately 42.6cm proximal to the distal tip.Additional kinks in the capture wire were located approximately 94.1, 98.3cm, and 134.63cm proximal to the distal tip.The hawkone was located approximately 8.8cm proximal to the spider fx distal tip.The distal housing had detached from the catheter at the proximal end of the housing where the coils initiate, distal the anchor pockets.The guide wire lumen on the housing assembly was disengaged from the proximal end to approximately 2.2cm distal to the proximal end.Zipper tearing was observed to the remained of the housing guide wire lumen.Damage was noted at the proximal end to the housing and the inner laser drilled coils.The rotating distal tip was bent.Inspection of the spider fx device revealed that there were several locations along the wire where the green ptfe coating on the spider fx device had worn away, probably due to excessive force and friction.Biological debris was observed in the filter assembly.Examination of the distal tip wire showed that fracture face of the wire where the coiled distal tip had detached.Inspection of the hawkone device revealed that the inner laser drilled coils proximal to the hinge location were detached and removed from the housing assembly.Tearing was observed at the proximal end of the rotating distal tip lumen.The hawkone catheter was returned connected to the cutter driver.It was noted that the torque shaft was bent beneath the strain relief.Inspection of the distal assembly revealed that the drive shaft and cutter remained attached to the catheter.It was noted that the inner laser drilled coils were wrapped around the drive shaft.The cutter was advanced approximately 2.7cm distal to the cutter window.Biological debris was noted around the inner laser drilled coils which were wrapped around the drive shaft.No anomalies were noted with the cutter window or cutter.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a hawkone atherectomy device with a spider fx embolic protection device during treatment of a 100mm calcified lesion in the patient¿ mid left common iliac artery.Vessel diameter reported as 6mm.Moderate vessel calcification and tortuosity are reported.Lesion exhibited 90% stenosis.A 7fr non-medtronic (destination) sheath was used.Ifu was followed and the devices were prepped without issue.Pre-dilation was not performed.Atherectomy was performed to debulk the vessel.An image was taken, and the physician decided to cut a little more.More passes were made with the hawkone device prior to attempted removal.On removal attempt the physician noted the spider fx wire had prolapsed on the hawkone device.Several attempted were made to attempt to untangle the wire unsuccessfully.The physician then pulled the device a little resulting in a break above the cutter window.The distal end of the hawkone broke off where the catheter and the cutter connected.The white tip was still on the filter wire.A snare was advanced to remove the detached portion, but this was unsuccessful.The procedure was stopped at this point, and the patient was transferred to hospital for removal of the distal end of the device which remained in the patient.The detached portion was removed from the patient.The patient has not received any additional treatment.No further injury reported.

• 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: 10435825
• Report Number: 2183870-2020-00258
• Device Sequence Number: 14122362
• Product Code: NTE
• UDI-Device Identifier: 00821684068380
• UDI-Public: 00821684068380
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/21/2020

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: 04/03/2022
• Device Model Number: SPD2-US-070-320
• Device Catalogue Number: SPD2-US-070-320
• Device Lot Number: B003748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 08/21/2020
• 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
• Patient Age: 80 YR
• Patient Weight: 86