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

Catalog Number	H965557320
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although it has been indicated that the used device will be returned to angiodynamics for evaluation, it has not yet arrived.Upon receipt of the 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 by angiodynamics' distributor in the uk, after a picc was placed, it developed a "longitudinal fracture along pasv valve leading from proximal end." the picc was removed and replace with no patient complications.The used device will 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 may 2017 angiodynamics complaint report was reviewed for the xcela pasv picc product family for the failure mode "hub broken/cracked." no adverse trends were indicated.The complaint was confirmed, as the female luer lock component of the purple valve was seen to be cracked just adjacent to the molded parting line.The most likely root cause for the crack is an over-tightened connection with a mating male luer (likely a needleless connector).Inadequate flushing of the device may also be a contributing factor.The directions for use (dfu) supplied with the reported picc device contain caution that "repeated over-tightening may reduce hub connector life," and not to use hemostats to "secure or remove devices with luer lock hub connections." recommended flushing techniques are also stated in the dfu.((b)(4)).

• Brand Name: ANGIODYNAMICS / XCELA
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6667219
• Report Number: 1317056-2017-00047
• Device Sequence Number: 72612
• Product Code: LJS
• UDI-Device Identifier: H965557320
• UDI-Public: H965557320
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K091261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2017

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: 06/30/2017
• Device Catalogue Number: H965557320
• Device Lot Number: 4892025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1