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

Model Number	CT75STSA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint # (b)(4).
Event or Problem Description
An end user reported after placing this smartport catheter in a patient, it snapped when the surgeon attempted to adjust the positioning.The device was removed and replaced.There was no patient harm or adverse event reported.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was one port with catheter tubing.As received, the port contained bio material {blood} inside and out.The port was returned with 9cm of catheter attached to the port and approximately 19cm.The catheter tubing and port contained blood inside and out.The fracture is jagged in appearance.Complete catheter fracture confirmed and no manufacturing non-conformance observed.The customer's reported complaint description is confirmed for fracture of the catheter tubing.Although no definite root cause could be identified, the catheter broke about 9 cm away from the port.It was possibly pinched where it enters the body.The rest of the catheter was found to be normal in appearance and measured within dimensional specifications.A potential root cause is excessive pulling on catheter tubing during adjustment, i.E.Tensile failure pulling catheter through tunnel region.Dhr review of the packaging and purchased component lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Labeling review: the instructions for use, (16608102-01, rev.A) which is supplied to the user with this catalog number, contains the following statements: potential complications: use of an angiodynamics port system involves potential risks normally associated with the insertion or use of any implanted device or indwelling catheter including but not limited to: these complications are well documented in literature and should be considered when a venous access device is utilized.Catheter disconnection or migration; catheter embolization; catheter fragmentation; migration; right arterial puncture.Precautions: to avert device damage and/or patient injury during catheter placement: avoid accidental device contact with sharp instrument and mechanical damage to the catheter material.Use only smooth-edged atraumatic clamps or forceps.Do not use the catheter if there is any evidence of mechanical damage or leaking.Avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen(s).Carefully follow the connection technique given in these instructions to insure proper catheter connection and to avoid catheter damage.Assure tight connection between port chamber and catheter.Implantation of attachable catheter: trim proximal end of catheter and advance through subcutaneous tunnel to the port pocket.Attach catheter to the port body.Blue strain relief mechanism: 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.Secure port body to underlying fascia using non-absorbable sutures and a minimum of three suture sites.Care should be exercised so that incision does not cross septum of port after closure.Warnings: maximum pressure recommended for power injection of contrast media with the smart port ct implantable ports is 300 psi and a maximum flow rate of 5ml/sec.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.Complaint reference (b)(4).

• Brand Name: SMART PORT
• Common Device Name: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801, ny
• MDR Report Key: 10185717
• Report Number: 1317056-2020-00111
• Device Sequence Number: 909126
• Product Code: LJT
• UDI-Device Identifier: H787CT75STSA0
• UDI-Public: H787CT75STSA0
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: CT75STSA
• Device Catalogue Number: CT75STSA
• Device Lot Number: 5519034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR