MAUDE Adverse Event Report: ANGIODYNAMICS, INC. NIT-VU HIGH-PERFORMANCE MICRO GUIDEWIRE

Catalog Number	H787058001245
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/09/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) notified the guidewire manufacturer of this complaint event on 16-jun-2014 via supplier corrective action request (b)(4).As part of a review of complaints related to distribution only products, (b)(4) identified that it does not have objective evidence that the manufacturer assessed this complaint event for mdr reportability.As a result of this review, (b)(4) chose to assess this complaint event for reportability and determined that it does meet the criteria to file an mdr.This retrospective mdr is being filed based on this review and to ensure complaint file is complete.As the reported disposable device was not returned, (b)(4) is unable to perform a device evaluation.The customer's reported complaint description of the guidewire broke off into the patient cannot be confirmed since no product was returned for evaluation.Without receiving product to evaluate, we are unable to definitively determine root cause for this event.Based on follow up information provided, the physician "felt tension when pulling wire back." it is possible that the wire sustained tensile, torsion and bending overload resulting in a fractured core and coil wire.A review of the lot history records was performed for the reported packaging lot for any deviations related to the reported defect of the complaint.The review confirmed that the packaging lot met all material, assembly, and performance specification.The instructions for use , which is supplied to the end user with this catalog number, states: "inspect the guidewire prior to use for tip shape, bends, kinks or coil separation.Do not use if damaged excessive force against resistance may result in damage to guidewire and catheter or vessel perforation".The purchased guidewire is manufactured and pre-packaged for (b)(4) by our supplier, neometics.The supplier has been notified via (b)(4).A review of the (b)(4) 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).Device unavailable for return.
Event or Problem Description
As reported to (b)(4) on june 12, 2014: during an abscess drain procedure of the gluteal muscle, under ct guidance, a nit-vu guidewire fractured inside of the patient.During the procedure, the catheter was advanced over the wire.The physician felt tension when pulling wire back.It was noted the guidewire had fractured when the doctor pulled it back from the catheter out of the patient.The fractured piece was not retrieved.It was reported the patient suffered no serious harm or injury due to the event.The reported defective device is not available for return to the manufacturer for evaluation.

• Brand Name: NIT-VU HIGH-PERFORMANCE MICRO GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6489381
• Report Number: 1319211-2017-00040
• Device Sequence Number: 16424795
• Product Code: DQX
• UDI-Device Identifier: H787058001245
• UDI-Public: H787058001245
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K890207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2017

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: Physician
• Device Catalogue Number: H787058001245
• Device Lot Number: MO23904
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2014
• Initial Report FDA Received Date: 04/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention