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

Catalog Number 10732203

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/02/2023

Event Type  malfunction  

Event Description

An end user experienced an issue when using the angiographic catheter from a soft-vu of 5f x 65cm 038 nb 6sh kit.During the procedure, the tip of the catheter detached inside the patient in the popliteal vein.The tip was able to be removed and the procedure was completed with a different device.It was reported the patient was stable due to this event.

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).

Manufacturer Narrative

Returned for evaluation was one (1) angiographic catheter.The returned catheters tip was detached.The tip shows stretching at the catheter shaft end.The nature of the break indicates possible difficulty in withdrawing the device or interference with the guidewire utilized.Additionally, significant longitudinal scraping along the catheter shaft was noted.Based on the description of the complaint, it may likely be concluded the stretching occurred during the procedure after guidewire insertion.The appearance and nature of the defect is consistent with excessive tensile force application to the tip beyond its elastic range.The cause of this interference cannot be conclusively determined in this case.The customer's reported complaint description of the tip detached from the catheter was confirmed.Tip material is soft and pliable and is not brittle.The root cause of the tip detachment cannot be definitively determined but likely root cause is excessive tensile force applied after guidewire insertion, i.E.Handling damage.This is evidenced by the stretched nature of the failure location.A review of the device history records was performed for the indicated 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; i.E.No ncr associated with reported failure mode.Labeling review: the instructions for use, which is supplied to the end user with this catalog number, contains a statement; "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." the ifu also states; "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.Reshaping of the catheter tip is not recommended.Physical damage to the catheter material can result when exposed to heat." 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: SOFT-VU SIZING ANGIOGRAPHIC CATHETER
• Type of Device: SOFT-VU 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 ; 5086587990
• MDR Report Key: 16645618
• MDR Text Key: 312524423
• Report Number: 1319211-2023-00015
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: H787107322035
• UDI-Public: H787107322035
• 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: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10732203
• Device Lot Number: 5753609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Female