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

Catalog Number	H965458120
Medical Device Problem Codes	Crack (1135); Difficult to Remove (1528)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	06/08/2018
Type of Reportable Event	Serious Injury
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 2018 angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "catheter fractured/migrated." no adverse trend was identified.The customer's reported complaint description of catheter difficult removal and snapped is not confirmed, as no sample was returned.No additional information regarding what is meant by "snapped" but treating this as catheter broke distal from the suture wing (fractured/migrated).Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.There were no reports of picc device malfunction during use of the device, just difficulty to remove at end of treatment.Patient tortuous anatomy and vein spasm are potential contributing factors for difficult to remove catheter tubing.Excessive force used to pull on catheter tubing during removal is potential contributing factor for catheter "snapped".The root cause of the catheter removal difficulty and subsequent fracture was unable to be determined.Guidelines for catheter use and care are provided in the instructions for use, which includes the following section regarding catheter removal: "catheter removal catheter removal is per the discretion of the physician in regards to the patient's therapy regimen.1.Position patient upright with arm at 45-degree angle outward from body.Maintain insertion site below level of heart.2.See dressing removal section.3.Open catheter stabilization device retainer lids and remove catheter from retainer.Note: it is preferred to use aseptic technique for the following steps.4.To remove catheter, grasp catheter between suture wing and insertion site and remove slowly, in small increments, keeping catheter parallel to skin surface.Do not grasp luer lock hub to remove catheter, as catheter damage may occur.5.If resistance is still met, follow institutional protocol for the management of difficult-to-remove catheters.6.To verify that entire catheter has been removed, measure and compare catheter length with initial length recorded at time of insertion.7.Apply generous amount of alcohol to loosen edges of catheter stabilization device.While lifting adhesive pad, gently stroke undersurface of pad with alcohol to dissolve adhesive.8.Following removal of catheter, cover insertion site with occlusive dressing for at least 24 hours." (b)(4).
Event or Problem Description
As reported by angiodynamics' distributor in (b)(4), following completion of chemo treatment, removal of picc was attempted in the outpatient department of (b)(6) hospital on (b)(6) 2018.The picc "became stuck, then snapped." the patient had had no prior problems with the picc.They returned to the hospital the next day and heat, massage and insertion of a guidewire were used to attempt removal.This was unsuccessful, so the patient was referred to the vascular surgeons at (b)(6) hospital, where the picc was successfully removed.The used device was discarded at the hospital.

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7736327
• Report Number: 1317056-2018-00151
• Device Sequence Number: 10992920
• Product Code: LJS
• UDI-Device Identifier: H965458120
• UDI-Public: H965458120
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

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: 07/31/2019
• Device Catalogue Number: H965458120
• Device Lot Number: 5231643
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 07/31/2018
• 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