MAUDE Adverse Event Report: SOFTVU SIZING ANGIOGRAPHIC CATHETER

Catalog Number 10733201

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

An distributor's territory manager reported an issue with a softvu rim 4fx65cm.035 angiographic catheter.The end user reported that the softvu angiographic catheter was used in a very calcified vessel and the tip was noted to look very fragile and loose after the procedure.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.The device was reported as available for return to the manufacturer for evaluation.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of catheter tip is fractured/loose cannot be confirmed as no sample was returned for evaluation.Without receiving product to evaluate, we are unable to definitively determine root cause for this event.Although a sample was not received, it was noted that the vessel that the catheter was introduced to was calcified, a possible contributing factor of the tip becoming damaged/loose could have been due to the conditions of the vessel.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 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 adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

Manufacturer Narrative

Returned for evaluation was an angiographic catheter.A review of the complaint sample indicated that the soft tip had become accordioned (bunched up) and kinked, consistent with difficulty and excessive force applied in removing the guidewire from the device during placement.The cause requiring this force cannot be ascertained, but a reduction in the id of the soft tip could lead to guidewire binding.A reduction in soft tip id can be present in the raw extrusion prior to processing or possibly generated during the sizing process (incorrect mandrel, worn mandrel, tolerance stack, or improper sizing technique).The condition of the soft tip at the site of the issue made ascertaining the id impossible, but the distal tip of the catheter was found to be in specification.The customer's reported complaint description is confirmed as catheter tip was observed to be accordioned/damaged.Although the tip damage to the returned sample was confirmed a definitive root cause cannot be determined.It was noted that the vessel that the catheter was introduced to was calcified, a possible contributing factor of the tip becoming damaged could have been due to the conditions of the vessel.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, 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 adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

Manufacturer Narrative

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

• Brand Name: SOFTVU SIZING ANGIOGRAPHIC CATHETER
• Type of Device: SOFTVU SIZING ANGIOGRAPHIC CATHETER
• MDR Report Key: 11117813
• MDR Text Key: 225125556
• Report Number: 1319211-2021-00003
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: H787107332015
• UDI-Public: H787107332015
• Combination Product (y/n): N
• PMA/PMN Number: K112452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/25/2021

1 Device was Involved in the Event

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: 06/30/2022
• Device Catalogue Number: 10733201
• Device Lot Number: 5481841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 12/18/2020; 04/07/2021; 04/07/2021
• Supplement Dates FDA Received: 01/28/2021; 04/23/2021; 04/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1