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

Catalog Number	H965457501
Medical Device Problem Codes	Crack (1135); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although no device sample will be returned, it has been indicated that a photograph of the retained portion of the sheath will be forthcoming.The introducer sheath is purchased by (b)(4) from (b)(4).They will be provided with the lot number and details of the event on 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 on voluntary medwatch form mw5082549, "during a groshong catheter placement a mini stick max/coaxial microintroducer kit was used.A portion of the introducer sheath broke off during withdrawal over the wire.The portion retained was 8.3cm as evidenced by the remaining 1.7cm sheath that was attached to the orange hub.The retained portion was located in the right atrium which was confirmed by cat scan.".
Additional Manufacturer Narrative
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 "sheath fractured/migrated." no adverse trend was indicated.The failed device from the reported event is supplied to angiodynamics by medron llc.A supplier corrective action request (scar) was sent to them along with a (blurry) photograph of the device provided by the end user hospital, who was unable to release the sample to angiodynamics.Medron was unable to definitely determine the root cause of the failure, however a previously examined device with a similar appearance was determined to have potentially been nicked by a sharp instrument, such as a scalpel, and then had the tubing pulled to failure during sheath removal / pulling on the hub.Medron's review of their device history records for the sheath show that all parts were manufactured according to specification and passed inspection criteria.(b)(4).

• Brand Name: ANGIODYNAMICS / MINI STICK MAX
• Common Device Name: VESSEL DILATOR
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8370756
• Report Number: 1317056-2019-00037
• Device Sequence Number: 1598695
• Product Code: DRE
• UDI-Device Identifier: H965457501
• UDI-Public: H965457501
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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: 10/31/2021
• Device Catalogue Number: H965457501
• Device Lot Number: 5396570
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 05/09/2019
• 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