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

Catalog Number	M00160M1222721
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It has been indicated that the device involved in the reported event will be returned to angiodynamics for evaluation, however it has not yet arrived.Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).
Event or Problem Description
As reported, an indwelling picc (placement date not known) was removed and replaced due to "a rupture in the catheter next to the proximal hub".No patient injury was reported.It was stated that the used catheter would 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 recent angiodynamics complaint report was reviewed for the xcela power injectable picc product family and the failure mode "extension leg hole proximal to suture wing." no adverse trend was indicated.In addition, this is the only reported complaint for this failure mode in the past 15 months for the xcela power injectable picc product family, as such, this is deemed to be an isolated incident.The reported complaint description cannot be confirmed as no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Since the hole in the extension tubing was reportedly observed after the placement procedure and the picc was in situ for some period of time it is not likely related to a manufacturing non-conformance but rather due to care/maintenance/damage to the picc.Manufacturing process controls for the picc devices include 100% in-process visual inspection for molding defects, and a guidewire insertion test to verify lumen patency.Additionally, all catheters are leak tested after the guidewire verification to ensure the catheters do not leak.(b)(4).

• Brand Name: ANGIODYNAMICS
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8451149
• Report Number: 1317056-2019-00050
• Device Sequence Number: 16203343
• Product Code: LJS
• UDI-Device Identifier: M00160M1222721
• UDI-Public: M00160M1222721
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2019

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: 12/31/2019
• Device Catalogue Number: M00160M1222721
• Device Lot Number: 5392782
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1