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

Catalog Number	H96560M1831041
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the reported sheath is purchased by angiodynamics from (b)(4), the returned sample will be sent to the manufacturer 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
During an ir picc placement procedure the radiologist went to break the peel-away sheath, and the tabs broke off.When the tabs broke off, the sheath slipped into the patient's arm and became unretrievable.They had to call in a cardiovascular surgeon to perform a cutdown and retrieve the sheath.
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 january 2017 complaint report was reviewed for the xcela pasv picc product family and the failure mode, " sheath handle detached - both." no adverse trend was indicated.The used sheath, as well as an unused, returned sheath from the reported lot, was returned to angiodynamics and the reported failure was confirmed.As the sheath is a purchased component for angiodynamics, the returned samples, as well as a supplier corrective action request (scar) were forwarded to greatbatch medical ltd, the manufacturer.The scar response from greatbatch stated that the root cause of the device failure was that the sheath tubing was placed too low in the handle during molding.Possible causes of this condition are operator error in tube placement, or the tube blowing off the core pin during the molding cycle.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 PASV
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5748231
• Report Number: 1317056-2016-00094
• Device Sequence Number: 10763338
• Product Code: LJS
• UDI-Device Identifier: H96560M1831041
• UDI-Public: H96560M1831041
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K091261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2017

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: 12/31/2017
• Device Catalogue Number: H96560M1831041
• Device Lot Number: 4997477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2016
• Supplement Report FDA Received Date: 03/27/2017
• 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
• Patient Age: 82 YR