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

Catalog Number	H965750385
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although it has been indicated that the device from the reported event will be returned for evaluation, it has not yet arrived at angiodynamics.Upon receipt of the returned sample and completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).Device not yet returned to manufacturer.
Event or Problem Description
As reported, on user/voluntary medwatch mw5068658, "while inserting the picc line, the catheter became crimped when attempting to remove stylet.Surgeon had to come and remove catheter surgically." it has been indicated that the used device will be returned to angiodynamics for evaluation.
Additional Manufacturer Narrative
A review of the device history records (dhr) was performed for the indicated packaging and picc assembly 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 september 2017 angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "catheter/guidewire fit issue - intervention required." no adverse trend was indicated.As no used samples were returned to angiodynamics despite multiple good faith efforts, the complaint is unable to be confirmed, nor can a root cause be determined.The guidewire is purchased by angiodynamics from heraeus medical.They were notified of the report via a supplier corrective action request (scar).Although they were unable to determine if there was a guidewire failure (no sample was returned), they reviewed the dhr for the guidewire used in the reported packaged device lot.No observations were made during the review of the records which could have contributed to the reported failure mode.Angiodynamics manufacturing process controls for the bioflo picc device include 100% in-process visual inspection for molding defects, a guidewire insertion test to verify lumen patency and all catheters being sprint tested after the guidewire verification to ensure that the catheters do not leak.((b)(4)).

• 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: 6571958
• Report Number: 1317056-2017-00037
• Device Sequence Number: 13648513
• Product Code: LJS
• UDI-Device Identifier: H965750385
• UDI-Public: H965750385
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K140266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2017

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: Physician
• Device Catalogue Number: H965750385
• Device Lot Number: 5154952
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: 04/25/2017
• Initial Report FDA Received Date: 05/17/2017
• Supplement Report FDA Received Date: 11/01/2017
• 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