MAUDE Adverse Event Report: ANGIODYNAMICS, INC MICRO-INTRODUCER KITS

Catalog Number H787065970155

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

The reported defective device has yet to be returned to the manufacturer for a device evaluation.Angiodynamics is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation.Will be sent via a follow up medwatch.Complaint # (b)(4).

Event Description

Per received user medwatch 0504240000-2019-8006: pt undergoing cerebral angiogram the site was injected with lidocaine 1 % overlying the right common femoral artery the groin and arterial access was gained using a micropuncture technique, with the access wire in place the md went to remove the micropuncture sheath the hub disconnected from the main body of the sheath - when the md pulled on the main body of the sheath, approximately one half of it came off.Approx.2 1/2 cm of the tip was missing and still on the wire, attempts to dissect with a hemostat down the wire to identify and remove - unsuccessful attempt.The left common femoral artery was accessed with ultrasound guidance, a 6f 11 cm sheath was placed and flushed, through this a snare was used to capture the distal end of the access wire and withdraw out the left femoral artery sheath - a 5cm sheath was placed over the wire into the right common femoral artery - a 70 cm kumpe was passed antegrade down the access wire and the tip of the was pushed out the left side of the groin - there was not harm to the patient all was retrieved.It was indicated the defective disposable device is available for return to the manufacturer for evaluation.

Manufacturer Narrative

Returned for evaluation was a sheath and a dilator.A visual inspection noted that the sheath was separated from the hub and broken in 2 pieces.The dilator was noted to be separated from the hub.The sample was forwarded to the vendor facility for evaluation.The customer's reported complaint description of the microaccess micro-introducer sheath was fractured is confirmed.Angiodyanmics' supplier was unable to determine a root cause for the reported failure.Potential root causes could have been due to high insertion force, patient anatomy, and procedureal complications.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).

• Brand Name: MICRO-INTRODUCER KITS
• Type of Device: MICRO-INTRODUCER KITS
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 8575001
• MDR Text Key: 143874932
• Report Number: 1319211-2019-00037
• Device Sequence Number: 1
• Product Code: DQT
• UDI-Device Identifier: H787065970155
• UDI-Public: H787065970155
• Combination Product (y/n): N
• PMA/PMN Number: K051655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: H787065970155
• Device Lot Number: 5289467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR