MAUDE Adverse Event Report: ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETER

Device Problems Device Damaged Prior to Use (2284); Insufficient Information (3190)

Patient Problems Patient Problem/Medical Problem (2688); No Information (3190)

Event Date 03/11/2016

Event Type  malfunction  

Manufacturer Narrative

The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.A review of the device history records was performed for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.

Event Description

As reported on (b)(6) 2016, a patient of unknown age and gender presented for an angiographic catheter placement.During preparation for the procedure, when the angiographic catheter was removed from the sterile packaging, it was noted the tip had fractured off inside of the packaging.The device was set aside and a new of the same device was used to successfully complete the procedure.It was reported the patient suffered no harm or injury due to this event as the device didn't come into contact with the patient.It was reported the defective disposable device is available for return to the manufacturer for evaluation.

Manufacturer Narrative

As the reported complaint sample was disposed of by the user and not returned, angiodynamics is unable to perform a device evaluation.Although the sample was not returned, the customer's reported complaint description of the soft tip breaking is confirmed based of the photographic evidence provided.The fracture occurred while removing the device from the packaging.The device did not make patient contact.A definitive root cause for the reported complaint description cannot be determined.A review of the lot history records was performed for the 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 catalog number, contains a statement; "reshaping of catheter tip is not recommended.Physical damage to the catheter material can result when exposed to heat".This type of complaint will continue to be monitored for trends.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.(b)(4).Device unavailable for return.

• Brand Name: SOFT-VU ANGIOGRAPHIC CATHETER
• Type of Device: ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury avenue; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 5553935
• MDR Text Key: 42084067
• Report Number: 1319211-2016-00050
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K14199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Hospital Service Technician
• Type of Report: Initial,Followup
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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