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

Model Number	CT80STPD
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An end-user reported that a patient's smartport that had initially been placed on (b)(6)2022, was having the device removed due to the completion of chemotherapy treatment.A pre-procedure x-ray determined the catheter had detached from the port and migrated to right atrium (previous x-ray from (b)(6) 2022 had confirmed the port was still attached.).The port was removed and catheter was removed using a snare via groin access.
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
Returned for evaluation was one (1) port with catheter tubing on outlet tube, blue boot connector and detached catheter tubing.As received, the customer returned the port with one cm of catheter tubing attached to outlet tubing and approximately 25cm of the catheter tubing for evaluation.The blue boot was returned by itself, i.E.Not attached to either the port or catheter tubing.During the disinfection process, the catheter and port were occluded with blood.The catheter tubing was fractured and detached at the 1 cm mark and the distal tip was the portion of the catheter tubing connected to the port outlet tube (backwards connection).The customer's reported complaint description of catheter tubing fractured and detached is confirmed, however, the end user assembled the catheter tubing backwards onto the port housing.This catheter tubing has a distal tip end (white) which is at the 0-1 cm marking and is different than the remainder of the light blue catheter tubing.The blue boot was returned already disconnected from the port and catheter tubing so it cannot be confirmed if the blue boot was also connected to the port housing backwards, but this is a likely potential situation given that the blue boot is assembled onto the catheter tubing (by angiodynamics) with the tapered end of the blue boot pointing toward white distal tip.The end user error in connecting the white distal tip of the catheter tubing to the port housing is the likely root cause of this catheter tubing fracture and detachment event.The rest of the catheter was found to be normal in appearance and measured within specification.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode 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.Labeling review: the smartport dfu contains the following statements regarding making the catheter connection to the port housing: "- insert catheter into sheath.Position the distal end of the catheter at the desired location.Peel away sheath while withdrawing it from vessel.Care should be taken not to withdraw catheter as sheath is removed.Catheter position should be confirmed radiographically.Secure catheter in place.- trim proximal end of catheter and advance through subcutaneous tunnel to the port pocket.Attach catheter to the port body.- slide the blue strain relief mechanism over the end of the catheter.The tapered end of the blue strain relief mechanism should point away from the proximal end of the catheter.For optimal results, the proximal end of the catheter should be dry.Slide the trimmed end of the catheter tip onto the stem until the catheter is flush with the stem flanges.Slide the strain relief mechanism over the catheter and onto the stem until it contacts the port body." 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
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 17070864
• Report Number: 1317056-2023-00071
• Device Sequence Number: 6688621
• Product Code: LJT
• UDI-Device Identifier: H787CT80STPD0
• UDI-Public: H787CT80STPD0
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K101017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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: 04/30/2025
• Device Model Number: CT80STPD
• Device Catalogue Number: CT80STPD
• Device Lot Number: 5733844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female