MAUDE Adverse Event Report: MEDTRONIC IRELAND HAWKONE 6FR; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number H1-M

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 10/29/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician was attempting to use a hawkone directional atherectomy to treat the mid sfa.The vessel was not pre or post dilated.The ifu was followed during, preparation, procedure and post procedure.It was reported that during withdrawal resistance was felt and the tip was detached.The procedure was completed by retrieving the tip.There was no patient injury reported.

Manufacturer Narrative

Device evaluation: the hawkone was returned inside a sealed saftpak biohazard bag.Within the bag a proportion of the spider fx was included.The filter assembly was visible within the rotating tip gw lumen.The hawkone was inspected.It was discovered it was separated into three pieces.The distal piece was the rotating tip was separated from the housing.Within the gw lumen of the rotating tip it was discovered the filter of a spider fx was protruding out from the distal tip of the rotating tip.Approximately 6cm of the spider fx tip wire was present.The spider fx coiled tip was bent, and the ro horseshoe was partially loaded the rotating tip.The tip wire was visible outside the proximal end of the h1 rotating tip.The proximal end of the rotator tip assembly included the flush mouth.It should be noted the tecothane was detached from this segment.The proximal end of the rotator tip showed a radial fracture.The second pie ce of the hawkone was the coiled housing.The distal end showed the stainless steel stretched out distally past the tecothane where the imprint of the flush mouth was located.The overall length was approximately 6cm.Zipper tearing was observed to the entire segment.To the gw lumen.The proximal end of the piece showed a flat tecothane surface.The holes over the anchor pockets were visible on the tecothane.The proximal end of the gw lumen disengaged and flapped distally.The third piece included the cutter window of the hawkone, the coiled housing proximal end was stretched out distally approximately 1.5cm from the anchor pockets.Pet was observed within the stretched-out coils from the proximal location of the coiled housing segment.Pet was observed tangled over the cutter assembly.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the lesion was in the right sfa.A 6 fr sheath and a spider fx were used in the procedure.The physician felt minimal resistance on the initial insertion of the hawkone.The device was removed.The lesion was then pre-dilated with a non-medtronic balloon.The hawkone was then re-inserted and one pass was made. the physician still felt a fair level of resistance and he withdrew the hawk. severe resistance was felt upon device withdrawal.The physician noticed the spider wire lock up on catheter and it was coming back with the hawk. the hawk nosecone broke off in the ipsilateral iliac (right) as the device would not pull completely into the 6 fr sheath.The 6fr sheath was removed and the hawk nose cone remained in the contra-lateral iliac (left), just above the access site.Guidewire prolapse is reported. the physician then got access from the right common femoral artery and placed a cross over 9 fr sheath.A non-medtronic snare to retrieve both the spider and the nosecone.All items were recovered.The patient had no clinical issues, and the patients leg does feel better from the intervention.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 6FR
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9361623
• MDR Text Key: 167814598
• Report Number: 9612164-2019-04858
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: 00643169968332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2022
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0009837165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0450-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention