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

Catalog Number H787107323015

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2017

Event Type  malfunction  

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 to angiodynamics on january 16, 2018: a flush catheter was placed inside patient.The catheter hub was connected to the power injector.Upon injection, it was noted there was air in the catheter.This was noted via flouro.The injector was unable to get any fluid through the tip pf the catheter and small bubbles were noted.The injection was immediately ceased before the air could enter the patient.A visible weak spot was noticed outside of the patient on catheter.The catheter was disconnected from injector and it broke off (catheter fractured).It was reported the fracture was close to the catheter hub.It was reported the patient suffered no harm or injury due to this event.The reported defective disposable device has been returned to the manufacturer for evaluation.

Manufacturer Narrative

Returned was a sv of 4fx65cm.035 nb pg catheter.A visual examination of the returned device noted the catheter shaft to be fractured approximately 29.7cm from the hub.The device met all dimensional specifications for this product.There was no evidence of material stretching.The customer's reported complaint description of a visible weak spot is confirmed.Although the complaint description is confirmed, a definitive root cause for the event cannot be determined.The most likely root cause would be a kink, or similar damage, in the catheter shaft, causing the weak spot.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.The instructions for use, which is supplied to the end user with this device, 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".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: 7247646
• MDR Text Key: 99315419
• Report Number: 1319211-2018-00008
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: H787107323015
• UDI-Public: H787107323015
• 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: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: H787107323015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR