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

Catalog Number H787137098015

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/23/2019

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.Complaint # (b)(4).

Event Description

As reported: an accuvu angiographic catheter was used in endovascular case.The catheter was inserted and removed from patient without incident multiple times.On one attempt to re-insert; the radiopaque tip was found to be broken/detached into multiple pieces (catheter and three fragments; two in biohazard bag for return to manufacturer and one remaining in patient's body).One of the fragments remains inside patient; no known injury at this time.The reported defective disposable device has been returned to the manufacturer for evaluation.

Manufacturer Narrative

Returned for evaluation was an opened softvu berrenstein catheter.A visual review of the catheter noted that the tip was detached from the catheter.Engineer review: "a review of the complaint sample indicated a fracture of the soft tip with no evidence of material stretching at the site of the failure.The catheter was inspected for visual indications of damage that could have led to compromised integrity, with none apparent." the customer's reported complaint description of the "the tip broke off" is confirmed.This failure mode is consistent with tip embrittlement associated with capa: c2013008.A material change to the tip was implemented; a material change to address the robustness of the catheter tip was implemented on (b)(6) 2017 per dcaf p007692 and co-085743.The complaint sample sub-assembly (lot: 5122032) 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: ACCU-VU SIZING ANGIOGRAPHIC CATHETER
• Type of Device: ACCU-VU SIZING ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury, ny NY 12804
• MDR Report Key: 9611619
• MDR Text Key: 176271044
• Report Number: 1319211-2020-00007
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: H787137098015
• UDI-Public: H787137098015
• Combination Product (y/n): N
• PMA/PMN Number: K112452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: H787137098015
• Device Lot Number: 5122032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 56 YR