MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / XCELA; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number	H965251050
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although it has been stated that the used sheath will be returned to angiodynamics, it has not yet arrived for evaluation.Upon receipt of the sample, and completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).
Event or Problem Description
As reported, during a picc placement procedure, both wings of a peel-away sheath detached.The sheath did not migrate and was able to be removed without complications.The used device will be returned to angiodynamics for evaluation.
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 august 2017 angiodynamics complaint report was reviewed for the xcela pasv picc product family and the failure mode "sheath handle detached - both." no adverse trend was identified.The sheath which is the subject of the event report is a purchased component for angiodynamics.Although the device was not returned for evaluation, a previous supplier corrective action report (scar) provided to the supplier, greatbatch medical ltd for a similar event stated that the likely root cause of this failure mode would be due to improper tube placement during molding.Greatbatch has initiated a capa to further investigate handle detachment issues.Angio dynamics incoming inspection of the sheaths includes a visual aql to verify that the sheath tubing is undamaged, is free of defects, meets dimensional specification, and that it properly breaks at the hub an separates into two complete pieces when the wings are pulled apart.((b)(4)).

• Brand Name: ANGIODYNAMICS / XCELA
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6590181
• Report Number: 1317056-2017-00041
• Device Sequence Number: 978606
• Product Code: LJS
• UDI-Device Identifier: H965251050
• UDI-Public: H965251050
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K070002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2017

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: 08/31/2018
• Device Catalogue Number: H965251050
• Device Lot Number: 5083479
• 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: 05/16/2017
• Supplement Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 09/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1