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

Catalog Number	H965458810
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device from the reported incident has been returned to angiodynamics, however the evaluation has not yet been conducted.Upon completion of the investigation a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported by angiodynamics' distributor in (b)(4), a picc as inserted in the right basilic vein for chmotherapy.The district nurse went to do dressing 1 week later.Good flashback.Flushed with 30 ml n-saline and injected 5 ml heparin 500.One week later patient returned to oncology.Line blocked.Sent to radiology.Assessed to be blocked and line removed.Picc out until able to flush.Picc completely blocked with clot to hub.Patient condition was reported to be "unaffected" by this event.The used picc has been returned to angiodynamics for evaluation.
Additional Manufacturer Narrative
In lieu of a reported lot number, a ship history report (shr) was generated for item number h965458110 in order to determine the last three lots shipped to the reporting customer in the six months prior to the procedure date.The three lots obtained through the shr were: (5251430, 5268494 and 5277747).The device history records for the lots obtained through the ship history report (packaging lots) were reviewed 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 bioflo picc product family and the failure mode "aspiration difficulty - removed." no adverse trend was identified.The bioflo picc from the reported event was returned in eleven {11} pieces with bio material {blood} all over it.Each piece of catheter tubing and valve were occluded with bio material {blood clots} inside.After the cleaning process, no difficulty was noted when flushing each piece of catheter tubing and the valve.When the valve was visualized microscopically, the valve disc was confirmed to be slit and centered.There were no molding/manufacturing related non-conformances noted to the returned sample.The infusion and aspiration pressures were measured on the pasv valve and were found to meet specification.The catheter tip id and od were also measured and met specification.The reported complaint was unable to be confirmed, nor could an exact root cause be identified, as no manufacturing non-conformances were observed during sample evaluation.A potential root cause for the occlusion reported in the catheter tubing is care and maintenance of the picc device, i.E.Adequate flushing of device.This is discussed in the directions for use provided with the device.(pr (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: 7564690
• Report Number: 1317056-2018-00098
• Device Sequence Number: 11202144
• Product Code: LJS
• UDI-Device Identifier: H965458810
• UDI-Public: H965458810
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

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 Catalogue Number: H965458810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR