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

Catalog Number H965952420

Device Problems Knotted (1340); Difficult to Remove (1528)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/10/2018

Event Type  Injury  

Manufacturer Narrative

Although it has been indicated that the used guidewire will be returned to angiodynamics, it has not yet arrived.Upon receipt, it will be forwarded to our guidewire supplier for evaluation.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

Event Description

As reported by (b)(4)' distributor in (b)(6), placing an xcela hybrid picc, "after puncturing a basal vein, the guidewire showed difficulties of insertion on the mark of 10cm.A small incision was made for the guidewire removal and it showed a deformation it like a little knot." there were no additional complications and the patient condition was reported as "satisfactory/good." the used device will be returned to angiodynamics for evaluation.

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 pasv picc product family and the failure mode "guidewire knotted." no adverse trend was identified.As received, the guidewire was not returned in its protective hoop.It was noted during the visual inspection that the tip of the guidewire was knotted.This device is purchased by angiodynamics from lake region manufacturing.The returned sample was forwarded to lake region for evaluation along with a scar (supplier corrective action request).Per the scar response, the observations made during the analysis found damage in the form of kinks/bends, an offset and knotting along the guidewire.An offset was present approximately 4mm from the distal tip.No other damage was noted on the returned guidewire.Both distal and proximal joints were intact when microscopically and functional examined.Based on the evidence presented by the sample and the information provided by the supporting documentation provided by the customer, the following may have contributed to the reported event: ifu not followed, excessive force, device forced against resistance, user failure in preparation for use, operational context, inexperience user, improper use, unanticipated user error, improper handling, and/or improper removal from packaging.(pr19600).

• Brand Name: ANGIODYNAMICS / XCELA
• Type of Device: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7566333
• MDR Text Key: 109974348
• Report Number: 1317056-2018-00100
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K111906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: H965952420
• Device Lot Number: 5037987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention