MAUDE Adverse Event Report: ANGIODYNAMICS MICRO-INTRODUCER SETS

Catalog Number	06597052
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
An end user reported an issue with this stf4f m.I.Kit.During a procedure, the nitinol tungsten 0.018" guidewire separated at the tip transition and got stuck in the patients fistula.This occurred after the micropuncture sheath was advanced over the wire.The fistula was clotted; therefore, the guidewire did not migrate but the physician had to snare the wire out.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.It was reported the defective disposable device is available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
Received for evaluation was a guidewire (p/n 06517001).Guidewire was returned in two pieces.The device was forwarded to angiodynamics' supplier of this product for evaluation and root cause determination via scar004164.They indicated that "the wire was found broken on the grinded core section, which means neither the glue exchange bond nor the welding was compromised." the reported complaint description of "the guidewire broke off" has been confirmed, however a definitive root cause cannot be determined.Per the supplier: "based on these results, the unit was found within the drawing specification.The core section is considered to be in conformance based, not only in the manufacturing router but to the measurement results described above of the returned unit.Therefore, this is not a manufacturing-related issue.It's most likely that this defect was generated outside the supplier's facilities during the manipulation of the unit.A review of the device packaging 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.Labeling review: the instructions for use which is supplied to the end user with this catalog number contains the following statement "the micro-introducer is designed for percutaneous introduction of a guidewire or catheter into the vascular system utilizing a 21 gauge needle stick.Gain percutaneous access with the 21 gauge needle.Advance the 0.018" guidewire through the 21 gauge needle.Withdraw the entry needle while leaving the 0.018" guidewire in place.Advance the micro-introducer over the 0.018" guidewire.Remove the 0.018" guidewire and the micro-introducer inner dilator.Advance up to a 0.038" guidewire or catheter through the micro-introducer sheath.Remove micro-introducer sheath." 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.Reference (b)(4).

• Brand Name: MICRO-INTRODUCER SETS
• Common Device Name: MICRO-INTRODUCER SETS
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 10148705
• Report Number: 1319211-2020-00037
• Device Sequence Number: 2164194
• Product Code: DQX
• UDI-Device Identifier: H787065970525
• UDI-Public: H787065970525
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

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: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 06597052
• Device Lot Number: 5468458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 98