MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION

Catalog Number H9654575991

Device Problems Material Fragmentation (1261); Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Angiodynamics is attempting to obtain additional information regarding the event and the usage of the device.It has been indicated that the used guidewire will be returned, but it has not yet arrived.As angiodynamics purchases the guidewire from heraeus medical, they will be sent a supplier corrective action request (scar) to notify them of the event and to evaluate the guidewire once it is available.A supplemental medwatch will be submitted upon completion of the investigation.(b)(4).

Event Description

As reported, during an access fistula procedure in the ir, the "floppy tip on the micro wire sheard off in the patient." detached portion was removed via snare, and the patient is ok.It has been indicated that the used guidewire will be returned for evaluation.

Manufacturer Narrative

The reported packaging lot (5293472) for item number h965457591 had purchased component item number 10610018 (angiodynamics lot 639175 [sl# pl01598]) and (b)(4) [sl# pl01763]) packaged in it.A review of the device history records was performed for the indicated 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 recent angiodynamics complaint report was reviewed for the mini stick product family and the failure mode "guidewire fractured/migrated." no adverse trend was identified.Although the guidewire was not returned for evaluation, a supplier corrective action response (scar) was sent to heraeus medical, angiodynamics' guidewire supplier, for information purposes.Although the exact cause of the reported event is unable to be determined without a sample evaluation, a possible root cause for the fractured guidewire may be the end user pulled the wire back through the needle.The directions for use packaged with the mini stick states: "the guidewire should not be withdrawn through the introducer needle.If the guidewire must be withdrawn while still inside the needle, simultaneously remove both the needle and the wire as a unit to prevent the needle from damaging the guidewire." ((b)(4)).

• Brand Name: ANGIODYNAMICS
• Type of Device: VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7498367
• MDR Text Key: 107724741
• Report Number: 1317056-2018-00063
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• PMA/PMN Number: K132713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

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
• Device Operator: Physician
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: H9654575991
• Device Lot Number: 5293472
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 04/24/2018
• Supplement Dates FDA Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention