MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS INC. MICRO ACCESS KITS; MICRO ACCESS AND MICRO INTRODUCERS

Catalog Number	H787065970145
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident 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 july 06, 2017 via user medwatch (b)(4): patient to cardiac cath lab for cardiac electrophysiologic study/catheter ablation on (b)(6) 2017.Micro-puncture wire broke and left a tiny piece in the left groin subcutaneous tissue area while trying to enter the left femoral vein in the beginning of the case.Peds echo done on day of procedure; no evidence of clot or thrombus formation in the left atrial appendage.On the day after the procedure, venous doppler report - no evidence of left lower extremity acute deep venous thrombosis.Xray of pelvis done (b)(6) 2017 - suggestion of very thin foreign body along the medial aspect of the femoral head likely representing small retained wire.Physician determined not to remove the fragment.Patient discharged home (b)(6) 2017.It was reported the defective disposable device is not available for return to the manufacturer.
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of the guidewire unraveling could not be confirmed because no sample was returned.A possible root cause for the reported complaint is that the end user pulled the guidewire back through then needle.The welded tip of the guidewire could become caught on the beveled edge of the needle causing the wire to become uncoiled and break, however, this cannot be definitively determined at this time as the reported defective device was not returned.A lot history records search revealed no quality related issues or manufacturing deficiencies at the time of manufacture.The instructions for use, which is supplied to the end user with this catalog number instructs the user to gain percutaneous access with the 21 ga.Entry needle.Advance the 0.018" guidewire through the 21 ga.Needle.Withdraw the entry needle while leaving the 0.018" guidewire in place.Advance the sheath/dilator set over the 0.018" guidewire.Remove the 0.018" guidewire".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.Complaint reference (b)(4).

• Brand Name: ANGIODYNAMICS INC. MICRO ACCESS KITS
• Common Device Name: MICRO ACCESS AND MICRO INTRODUCERS
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6756713
• Report Number: 1319211-2017-00077
• Device Sequence Number: 1412369
• Product Code: DQX
• UDI-Device Identifier: H787065970145
• UDI-Public: H787065970145
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051655
• 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,Followup
• Report Date (Section B): 09/20/2017

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: H787065970145
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 09/21/2017
• 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
• Patient Age: 18 YR