MAUDE Adverse Event Report: UNKNOWN; DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event evaluation: a dimensional verification along with a review of the complaint history, drawings and a visual inspection of the returned product was conducted during the investigation.One used mini titanium vital port was returned with this complaint along with two lengths of catheter (~3 cm and ~34.5 cm) and a catheter lock.The product rpn is unknown but its size was confirmed.Per the customer report, the device was implanted for 5 years before a fracture of the catheter was reported.The 3 cm segment of catheter was attached to the vital port when received.Visual inspection of the catheter confirmed the report of fracture.The device was inspected under magnification, which confirmed the presence of burnishing and wear on the od of both segments of catheter.No other signs of wear, punctures, or anomalies were observed on the catheter or the other segments.No evidence of use of the suture holes was observed.A dimensional verification of the catheter and outlet tube were performed, and all dimensions measured were within the acceptance criteria.Because the device's lot number was not provided, a review of manufacturing records could not be performed.There was no evidence of a manufacturing nonconformity.We will continue to monitor this product.Per the quality engineering risk assessment (qera), no further action is required.

Event Description

On (b)(6) 2009 the device was implanted in the upper arm.Since then, regular ct follow-up has been performed every year.On (b)(6) 2015 a ct showed that the catheter was ruptured and migrated to the right atrium ~ the right ventricle ~ the pulmonary artery.Since the patient had not been aware of any symptoms like thoracic pain, the catheter rupture and migration had not been noticed until the follow-up ct.On (b)(6) 2015 the catheter was removed by a physician who belongs to radiology department.According to safety department of the hospital, it was possible that a heparin lock had not been performed since the hospital had no medication record of the patient's.No port re-implantation is planned.The patient is free of complications.

• Brand Name: UNKNOWN
• Type of Device: DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5397016
• MDR Text Key: 37040850
• Report Number: 1820334-2016-00054
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1