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

Catalog Number	H787137098045
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2017
Type of Reportable Event	Malfunction
Additional 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.(b)(4).
Event or Problem Description
As reported to angiodynamics on march 14, 2017: the 4fr pigtail accuvu catheter failed yesterday ((b)(6) 2017) evening.The black radiopaque distal tips detached from the catheter while it was on the back table.The physician felt resistance when he was advancing the catheter over the wire.The catheter entered the patient but was still in the sheath.They removed the catheter and the tip had sheared off.The patient was not affected by this event.It was reported the defective disposable device is available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was an accu-vu pt 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, 5 mm from the weld joint.The fractured off piece appears stretched in the area near the fracture site.The remainder of the tip is "accordioned" and severely deformed.No signs of brittleness were noted on the soft tip.The device was analyzed by the manufacturing engineer (me) for angiographic catheters.An.035" was passed thorough the shaft of the device without issue.The fractured tip required physical manipulation to accept the wire due to the damage.The me dissected the tip and found no occlusions or suspicious particulate that could cause resistance.No signs of brittleness were noted.The customer's reported complaint description of accu-vu tip fracture is confirmed.Although the reported complaint description is confirmed, a definitive root cause for the event cannot be determined.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 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." the ifu also states the following regarding the tip straightener, "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 trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).

• Brand Name: ACCU-VU SIZING ANGIOGRAPHIC CATHETER
• Common Device Name: ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6464816
• Report Number: 1319211-2017-00041
• Device Sequence Number: 591360
• Product Code: DQO
• UDI-Device Identifier: H787137098045
• UDI-Public: H787137098045
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K112452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: H787137098045
• Device Lot Number: 5097081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 06/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1