MAUDE Adverse Event Report: ANGIODYNAMICS SMART PORT; PORT & CATHETER,

Model Number	CT66LTPD-VI
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
An end user reported issues with ct lowprofile with valved introducer, smartports.On 6-8 different occasions, the peelable sheath has been breaking into pieces when the introducer is broken apart, after the catheter has been advanced through.It was reported that the wings remained intact, that it was the orange and clear part of the introducer that breaks into 2 to 4 pieces.Some pieces fly off the sterile field an land on the floor, other pieces around the port site.This requires the physician to carefully remove all the pieces to ensure none are left inside of the patient.The procedures were completed successfully and the patients did not experience any adverse effects, harm, or require medical intervention as a result of these incidents.All occurrences have happened within the last month, with the same lot number.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of the "sheath has been breaking into pieces when the introducer is broken apart" could not be confirmed as no sample was returned for evaluation.The 7f sterile valved introducer pg is a purchased device from supplier, (b)(4).Scar004324 was sent to oscor for dhr review of supplier lot {dp-12450}.As per scar004324 results, the device history records were reviewed to confirm that the devices passed all applicable in process and final inspections.The reported packaging lot (5665261) for item number h787ct66ltpdvi1 had purchased sheath/introducer component item number vi7 (angiodynamics lot dp-12450} packaged in it.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; i.E.No ncr associated with reported failure mode.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: SMART PORT
• Common Device Name: PORT & CATHETER,
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• MDR Report Key: 11797336
• Report Number: 1317056-2021-00097
• Device Sequence Number: 3854829
• Product Code: LJT
• UDI-Device Identifier: H787CT66LTPDVI1
• UDI-Public: H787CT66LTPDVI1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2021

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: 01/31/2024
• Device Model Number: CT66LTPD-VI
• Device Catalogue Number: CT66LTPDVI
• Device Lot Number: 5665261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 07/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1