MAUDE Adverse Event Report: ANGIODYNAMICS, INC.; ANGIOGRAPHIC CATHETER

Device Problems Crack (1135); Device Issue (2379)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2016

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.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.(b)(4).

Event Description

As reported (b)(6) 2016, a patient of unknown age and gender presented for an medical procedure.It was reported that during prep for the procedure, the tip broke off of an accu vu marking catheter.The tip broke off while threading the catheter over a wire outside of the patient so the patient was not affected.The reported defective disposable device is available for return to the manufacturer for evaluation.

Manufacturer Narrative

Returned for evaluation was a soft-vu of catheter.The guidewire used during the event was not returned.A visual review of the device noted that a piece of the soft tip is fractured off (fractured piece not returned).3 mm of the remaining soft tip appears stretched and a portion of the catheter shaft appears to be flattened.A stock guidewire was unable to be advanced through the flattened section.No obvious sign of brittleness was noted on the soft tip.There is no report of difficulty advancing the wire through the shaft.The only defect reported is a tip fracture.The flattened area is most likely a result of the packaging conditions the device was returned in.Functional review: an attempt was made by the manufacturing engineer (me) for angiographic catheters, to duplicate this complaint using a guidewire with an od that is larger than the suggested size.With the oversized wire in place in the catheter, the tip did stretch and fracture.It was noted during the me evaluation that significant force was required to reproduce the failure.The customer's reported complaint description of soft-vu tip fracture is confirmed.Attempts were made to determine the size guidewire used during the event, but these efforts were unsuccessful.The most likely root cause to this complaint could be due to excessive force administered while advancing the wire or if the user used a larger size guidewire than recommended.Without receiving additional information about the wire, the root cause cannot be definitively determined.A review of the lot 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 catalog number, contains a statement; "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." 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.(b)(4).

• Type of Device: ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 603 queensbury avenue; queensbury, NY 12804 ; 5187424488
• MDR Report Key: 6178525
• MDR Text Key: 62531487
• Report Number: 1319211-2016-00167
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• 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