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

Catalog Number	50722631
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint of angiographic catheter sheath (strain relief) detached during procedure use could not be confirmed as no complaint sample was returned for evaluation and the customer did not provide any photos of the damaged product.Without receiving a sample for evaluation, a definitive root cause cannot be determined.A device history records search for the packaging/assembly lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.During the device assembly process, manufacturing 100% visualizes catheters for any defects.Labeling review: based on the event description, the angiographic catheter (tip straightener specially) was not used in accordance with it labeling.Tip straightener was inadvertently inserted into the patient rather then pulled back and off the catheter shaft.The instructions for use, which is supplied to the end user with the angiographic catheter contains the following statements: warnings 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.For catheters fitted with a tip straightener, utilize the device to straighten out the catheter tip.Do not straighten tip using other means.A.To straighten the tip, hold the distal end of the tip straightener between the thumb and forefinger and then pull the straightener to the distal end of the catheter.B.Once the tip is straight, place the catheter tip over the positioned guidewire and introduce the catheter into the vasculature.C.To remove the tip straightener from the catheter, gently slide the straightener to the proximal end of the catheter (towards the strain relief).Continue to pull gently until the straightener opens and slides off the catheter.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).
Event or Problem Description
An end user reported an issue with a soft-vu 90pt 6f x 100cm 038 b 10sh catheter.The catheter introducer cheater on the end of the catheter [tip straightener sleeve tubing], that is used to straighten the tip of the catheter, was introduced into the patient during a pulmonary embolism case.This piece went unnoticed during the pe case.The patient returned to their room and was having complications.The next day the patient went for a ct of the chest where a foreign body was found in the pulmonary artery.The patient then underwent a foreign body retrieval and the piece was removed from the patient.A complete root cause analysis was completed and we are asking that angiodynamics makes this plastic piece a different color other than white.Perhaps having this piece a bright color will help prevent the object from being entered into a sheath and ultimately the patients body.

• Brand Name: SOFT-VU SIZING ANGIOGRAPHIC CATHETER
• Common Device Name: 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: 17736650
• Report Number: 1319211-2023-00053
• Device Sequence Number: 17554885
• Product Code: DQO
• UDI-Device Identifier: H787507226315
• UDI-Public: H787507226315
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K112452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 50722631
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 57 KG