MAUDE Adverse Event Report: COOK VASCULAR INC VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT; DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number G26489

Device Problem Fluid/Blood Leak (1250)

Patient Problem Extravasation (1842)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6) (b)(4).) manufacture of this device was discontinued in november 2017.

Event Description

As reported a cook vital-port detached silicone catheter titanium infusion port (ip-s5116w-mpis-nt) showed extravasation and a catheter defect with leakage.As a result, the chamber and the catheter had to be removed from the patient.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Additional information: h6- ec method code desc - 1: changed to testing of actual/suspected device (10).H6- ec method code desc - 2: added historical data analysis (4109).H6- ec method code desc - 3: added analysis of production records (3331).H6- ec results code desc - 1: changed to mechanical problem identified (180).H6- ec conclusions code desc - 1: changed to failure to follow instructions (18).Investigation-evaluation: one mini vital port, one catheter hub/lock and one catheter were returned on this complaint, all used.The customer complaint/event that was reported entered into trackwise:"catheter defect / leaking product coming back for examination." the quality assurance department performed an investigation on the returned used device.The catheter hub/lock was disconnected from the port outlet.There was evidence/bruising on the catheter hub/lock tubing that it had been pushed over the port, however there were two gashes on the piece.The catheter was approximately 21.5 inches in length.It was noticed that both ends of the catheter were jagged/uneven.There were puncture marks evident in the septum of the device, however there were no signs that any of the suture holes were utilized.There were needle marks that were evident on the port housing itself.There were no occlusions in the catheter when flushed.The port showed occlusion when flushed, but may have been due to dried blood because during the flush, it no longer was occluded.The used returned device showed no signs of suture usage, the septum had puncture marks in it, and there were two gashes in the catheter hub/lock.It is possible that these gashes were from the injection needle due to no sutures being present (not sutured in place) and possible moving of the port.These gashes may have resulted in the leaking product.Per ifu (fm-1270 rev 001): "the titanium or polysulfone port body has suture points that permit anchoring.", "failure to adequately anchor the port to the fascia increases the risk of catheter fracture and/or disconnection which could result in catheter migration.", "a trained clinician is responsible to evaluate the health status of the patient, the integrity of the port system and the ability of staff to properly access the system for power injection.", "do not place sutures on catheter, as catheter may be compromised.", "improper catheter connection may result in catheter damage, leakage, or possible disconnection.", "use of the vital-port system involves potential risks normally associated with the insertion or use of any implanted device or indwelling catheter.These include, but not limited to:.Puncture.Catheter disconnection.Fracture, fragmentation.Rupture.", "three sutures, with at least one at each end of the port, are recommended." and "it is suggested that the clinician consider removing the vital-port system upon completion of treatment.".The device history record (dhr) was reviewed, including the manufacturing and quality control records.All process steps were complete and signed off by trained personal.There are no signs in the dhr to indicated that this vital port was shipped to the field nonconforming.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Catheter defect / leaking product coming back for examination.Cc form.Port catheter showed extravasation so the chamber and the catheter have been removed without any problems.

• Brand Name: VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT
• Type of Device: DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 9559831
• MDR Text Key: 220788134
• Report Number: 2522007-2020-00001
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00827002264892
• UDI-Public: (01)00827002264892(17)190731(10)N139904
• Combination Product (y/n): N
• PMA/PMN Number: K931586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: G26489
• Device Catalogue Number: IP-S5116W-MPIS-NT
• Device Lot Number: N139904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/07/2020
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention