MAUDE Adverse Event Report: ANGIODYNAMICS XCELA POWER INJECTABLE PICC; PERIPHERALLY INSERTED CENTRAL CATHETER,

Catalog Number	M001456710
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported: the peelaway sheath did not breakaway cleanly, leaving a fragment inside the patient, which had to be recovered by the picc inserter.It was logged as a serious incident on the hospital's datix system however no harm caused to the patient.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a sheath.As received, the sheath was returned in four pieces.Both handles were detached from the sheath tubing.The device was forwarded to angiodynamics' supplier of this product for evaluation and root cause determination.The reported complaint description is confirmed.The root cause for the defect was determined to be a supplier manufacturing issue.Per the supplier's investigation: the mold does not fasten the tube adequately during the over-molding process, causing it to move down the core pin and does not create an adequate bond between the sheath and the handle.This non-conformance was not detected as current visual inspections performed during the molding operation includes all mold characteristics and magnification can be used when required.There is no clear visual aid showing defective samples (exposed hole and/or split).A retention fixture was validated and implemented as a corrective action.The visual aid showing a defective part will be posted in molding operations qualification of tube retention for all ptfe introducer part numbers.A review of the device history records was performed for the reported 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.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).

• Brand Name: XCELA POWER INJECTABLE PICC
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER,
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8893021
• Report Number: 1317056-2019-00102
• Device Sequence Number: 241010
• Product Code: LJS
• UDI-Device Identifier: M001456710
• UDI-Public: M001456710
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K070002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: M001456710
• Device Lot Number: 5430656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 10/30/2019
• 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: Other