MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYANAMICS / MINI STICK MAX; VESSEL DILATOR

Catalog Number	H965457491
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device from the reported event was returned to (b)(4).It has been forwarded to the manufacturer, intromed, for evaluation along with a supplier corrective action request (scar).Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).
Event or Problem Description
As reported a micro puncture sheath broke off in an occluded graft in the patient.The physician left it in place, as it was not considered to be at risk of migration.A used sample has been returned to (b)(4) for evaluation.
Additional Manufacturer Narrative
A review of the device history records (dhr) 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 (b)(6) 2017 angiodynamics complaint report was reviewed for the ministicks product family and the failure mode, "sheath fractured/migrated." no adverse trend was identified.Returned for evaluation was one sheath hub with approximately ½ inch of tubing attached.It was forwarded to angiodynamics' supplier, intromed, along with a supplier corrective action request (scar).Intromed's review of the sample under magnification confirmed that the sheath tubing was not snapped or fractured at the hub junction as described in the complaint description, but rather tubing was fractured/tore at the location approximately 1.5 to 2.0 centimeters below the molded hub joint (tubing tensile failure).Additional magnified inspection of the failure location found that the tear appeared to have propagated from a nick or slice in the tubing {consistent with a cut that would be formed with a scalpel} as indicated by the clean, straight cut edges traveling at an angle distally through at least one half of the sheath tube.Review of a similarly reported complaint event showed that the most likely root cause of the damage was a cut or slice from a sharp cutting instrument such as scalpel followed by tensile load significant enough to cause separation in the sheath tubing segment.Intromed also reviewed their dhr records for the noted lots and found no discrepancies related to this defect during manufacturing.(b)(4).

• Brand Name: ANGIODYANAMICS / MINI STICK MAX
• Common Device Name: VESSEL DILATOR
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5973551
• Report Number: 1317056-2016-00146
• Device Sequence Number: 16253801
• Product Code: DRE
• UDI-Device Identifier: H965457491
• UDI-Public: H965457491
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K132713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2017

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: 03/31/2019
• Device Catalogue Number: H965457491
• Device Lot Number: 5004526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2016
• Supplement Report FDA Received Date: 04/06/2017
• 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