MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; GUIDEWIRE

Catalog Number	H965960006031
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device has not yet been returned for evaluation.Upon receipt of the sample it will be forwarded to angiodynamics' supplier, lake region mfg., along with a supplier corrective action request (scar).A supplemental medwatch will be submitted upon completion of the investigation.(b)(4).Device not yet returned to manufacturer.
Event or Problem Description
As reported: "surgeon took the guidewire, inserted it and they had difficulty pulling it out and the wire broke off.It was inserted thru the r4 catheter and they said the catheter did not advance past mid arm level so at that point they decided to remove the catheter and wire and use an alternative groin approach.The catheter came out of the sheath and that's when the surgeon found out that the core of the wire was snapped and only the coils were seen coming out of the sheath.So they had to send the patient to a different department, (b)(4) lab, who tried to snare the damaged wire.He was able to pull the coil wire out of the patient.The patient had to be kept overnight because of this." it has been indicated that the used guidewire will be returned for evaluation.
Additional Manufacturer Narrative
A review of the device history records was performed for the reported packaging lot (10635551) for item number h965960006031 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 january 2017 angiodynamics complaint report was reviewed for the angiographic guidewire product family and the failure mode, "guidewire fractured." no adverse trend was identified.As the guidewire is a purchased component for angiodynamics, the returned sample was forwarded to our supplier, (b)(4), along with a supplier corrective action request (scar).(b)(4) evaluation stated that the sample presented "cuts and fractures of the core wire, safety ribbon wire, and outer coiling wire.When the wire was dissected, the fractured safety ribbon presented indications of ductile, tensile overload.The proximal joint appeared to be correct and intact, and the guidewire appeared to be dimensionally correct.A review of (b)(4) device history records did not indicate any manufacturing defects which could have impacted on the reported event.The nature of the damage, combined with the end user's event description, suggests that the "distal tip region came into a constraint condition and sustained the fracture of the safety ribbon wire and stretched coil damage" when removing the catheter and guidewire.Although it is not possible to determine exact root cause, clinical and procedural factors appear to have impacted on the event.(b)(4).

• Brand Name: ANGIODYNAMICS
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5662513
• Report Number: 1317056-2016-00064
• Device Sequence Number: 20629
• Product Code: DQX
• UDI-Device Identifier: H965960006031
• UDI-Public: H965960006031
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K935170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: H965960006031
• Device Lot Number: 10635551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2016
• Supplement Report FDA Received Date: 03/16/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 80 YR