MAUDE Adverse Event Report: ANGIODYNAMICS INC SOFT-VUE HEADHUNTER 1; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number H787107089030

Device Problems Material Fragmentation (1261); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/28/2018

Event Type  Injury  

Event Description

A 5 french headhunter 1 catheter tip broke and was initially dislodged into the lower thoracic aorta then embolized into the right common femoral artery.Five (5) attempts of retrieval were performed with the last being successful.During each of the 4 retrieval attempts, tiny pieces of the catheter were noted to breakdown.These resulted in nonsignificant vascular branches into the muscular bed of the bilateral thighs.This sheath was exchanged for a 6 french sheath.A 6 french snare device was attempted to retrieve the catheter from the thoracic aorta which has resulted in a small fragment that appeared to embolized into the left femoral profunda artery.The device fragment was then moved into the right common iliac artery.A second attempt at retrieval with a snare device was performed in the right common additional small fragment embolization to a muscular branch off the muscular branch of the right femoral profunda.In addition the catheter fragment has now embolized into the common femoral artery.Vascular surgery was consulted, they recommended further attempts of endovascular catheter retrieval.The left common femoral artery was then accessed with a micropuncture stick then dilated up to a 6 french with a reversed curve guiding catheter placed across the right common iliac to obtain proximal control over the fractured fragment.Snare device was again utilized to perform a third retrieval which did result in additional fragment embolization this time into a small muscular branch off the right superficial femoral artery.Another fourth attempt was performed that was unsuccessful, a fifth attempt was then performed which was successful in retrieving the fractured catheter.Both the fractured catheter and main body of the catheter was submitted further assessment by the manufacture, which were also been informed by the incidence.

• Brand Name: SOFT-VUE HEADHUNTER 1
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ANGIODYNAMICS INC
• MDR Report Key: 8142302
• MDR Text Key: 130032091
• Report Number: MW5081939
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/04/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: H787107089030
• Device Catalogue Number: 10708903
• Device Lot Number: 5036266
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 93