MAUDE Adverse Event Report: ANGIODYNAMICS ACCUVU SIZING ANGIOGRAPHIC CATHETER

Catalog Number 13709703

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/03/2022

Event Type  malfunction  

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).

Event Description

An end user reported an issue with an av 5 100 035 of 1cm 21ro sizing catheter.During the procedure, the marker fell off, into the patient.The decision was made to leave the marker in situ.The procedure was completed with this catheter.The treating physician attributed the markerband detachment possibly to its use with the cook rups set.During the procedure, the catheter is withdrawn through the metal cannula several times during a case and in doing so, it may have caused the markerband to detach.The patient did not experience any adverse effects or harm as a result of this incident.

Manufacturer Narrative

Returned for evaluation was an angiographic catheter.An examination of the returned sample confirmed that one of the ro markers had migrated and two were missing altogether.Marker band #18 (from the distal end) had migrated from its original position on the shaft and was abutting #17.There was evidence that the marker bands were embedded properly, evidenced by prominent depressions in shaft at original site of the bands and the inspection of the bands that remained intact.Several ro bands appeared to be badly scraped and leaving residue on the shaft material in several areas over the length of the shaft.There are scrapes on the 2nd and 3rd most distal ro bands.In addition to the scrapes on the ro bands, there was a gouge in shaft between the #9 and #10 bands, indicating contact with a hard, sharp surface such as the metal cannula described in the original complaint above.The customer's reported complaint description of markerband detached from catheter is confirmed.The sample returned was noted to have 2 markerbands missing and one dislodged.Based on event description that catheter was used inside of another device (metal cannula) and the evaluation of the returned complaint sample, the likely root cause of the markerband detachment is handling damage during use.Inserting the angiographic catheter inside a metal cannula is not a typical use of this device and likely contributing to this event.There are inspections throughout the manufacturing process to ensure proper assembly including 100% visual inspection for marker band presence and location, embedding and adhesion, ro band appearance, and shaft damage.There is no indication that there were quality issues in regard to any of these attributes prior to use.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported failure mode 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).

• Brand Name: ACCUVU SIZING ANGIOGRAPHIC CATHETER
• Type of Device: ACCUVU SIZING ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 13840066
• MDR Text Key: 287899414
• Report Number: 1319211-2022-00014
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: H787137097035
• UDI-Public: H787137097035
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13709703
• Device Lot Number: 5713689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2021
• 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