MAUDE Adverse Event Report: ANGIODYNAMICS, INC SOFT-VU SIZING ANGIOGRAPHIC CATHETER

Catalog Number H787107197095

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).

Event Description

As reported: during a splenic emoblization procedure using a softvu cobra3 angiographic catheter, the catheter tip detached in side of the patient.The device and tip were removed and set aside.A new of the same device was used to complete the procedure.The patient suffered no permanent harm or injury due to this event.The reported defective disposable device has been returned to the manufacturer for evaluation.

Manufacturer Narrative

Returned for evaluation was a soft-vu catheter.A visual review of the device noted that the tip is separated from the catheter shaft.The fractured tip was not returned.The customer's reported complaint description of the tip of a soft vu cobra3 catheter broke off is confirmed.This failure mode is consistent with tip embrittlement associated with a capa previously opened to address the material of the catheter tip.A material change to address the robustness of the catheter tip was implemented on (b)(6) 2017.The complaint sample sub-assembly (lots 5098555, 5098557) was manufactured before the implementation of this material change.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.Labeling review: the instructions for use (ic 444), which is supplied to the end user with states; "never advance or retract an angiographic catheter or guidewire against resistance.This may result in damage to the vessel, the product, or both.Do not attempt to hand straighten the tip of any curved tipped catheters which are furnished with a tip straightener.This may result in damage to the product.Tip straighteners are furnished on all catheters intended to be straightened with the aid of a tip straightener.Always use a guidewire to remove the catheter from the vasculature.Failure to do so may result in damage to the vessel, puncture site, product, or all three.The maximum pressure limit of catheters intended for flush angiography is stated on the catheter package.When using a pressure injector, do not exceed the stated maximum pressure.Catheters intended for selective angiography do not have a maximum pressure limit stated on the catheter package.Typical flow rates of up to 10cc per second are stated with pressure generated to achieve these typical flow rates.Never advance or retract an angiographic catheter or guidewire against resistance.This may result in damage to the vessel, the product, or both.Angiodynamics angiographic catheters are designed for use with specific guidewire diameters.The recommended maximum guidewire diameter is specified on the catheter label".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: SOFT-VU SIZING ANGIOGRAPHIC CATHETER
• Type of Device: SOFT-VU SIZING ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 9179144
• MDR Text Key: 162020447
• Report Number: 1319211-2019-00092
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: H787107197095
• UDI-Public: H787107197095
• Combination Product (y/n): N
• PMA/PMN Number: K112452
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: H787107197095
• Device Lot Number: 5097674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention