MAUDE Adverse Event Report: SORIN GROUP USA, INC. RAP FEMORAL VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number 200-150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Erythema (1840)

Event Date 10/05/2014

Event Type  Injury  

Manufacturer Narrative

Patient identifier was not provided.The lot number and expiration date were not provided with the medwatch report.This information will be forwarded in a follow up report if and when made available.Mfg date: the lot number is unknown, so the manufacture date cannot be determined.This information will be forwarded in a follow up report if and when made available.Sorin group received a user medwatch report (b)(4) on april 28, 2016, stating that a patient developed a rapidly progressing erythema of the bilateral groins and scrotum, increasing vasopressor requirement and continuous febrility.The patient had undergone mitral valve replacement in 2014, which involved a cardiac catheterization through the groin utilizing anrap femoral venous cannula.A ct scan revealed a foreign object in the patient, which was retrieved and found to be a green, 0.035 inch guidewire.The guidewire was removed from the patient in one piece.The customer sent a photograph of the guidewire, which appears to be 15 to 25 inches long.An exact length cannot be determined from the photograph.The reported catalog number does not come with a guide wire, so it is unknown if the guidewire is distributed by sorin group usa.The customer has stated that the device is not available for return.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.Device not available for return.

Event Description

Sorin group received a user medwatch report (b)(4) on april 28, 2016, stating that a patient developed a rapidly progressing erythema of the bilateral groins and scrotum, increasing vasopressor requirement and continuous febrility.The patient had undergone mitral valve replacement in 2014, which involved a cardiac catheterization through the groin utilizing a rap femoral venous cannula.The patient was taken to the operating room for explorative surgery to rule out necrotizing soft tissue infection.A ct scan revealed a foreign object in the patient, which was retrieved and found to be a green, 0.035 inch guidewire.The guidewire was removed from the patient in one piece and sent to pathology.

Manufacturer Narrative

Sorin group received a user medwatch report (b)(4) on april 28, 2016, stating that a patient developed a rapidly progressing erythema of the bilateral groins and scrotum, increasing vasopressor requirement and continuous febrility.The patient had undergone mitral valve replacement in 2014, which involved a cardiac catheterization through the groin utilizing an rap femoral venous cannula.A ct scan revealed a foreign object in the patient, which was retrieved and found to be a green, 0.035 inch guidewire.The guidewire was removed from the patient in one piece.A photograph of the guidewire was submitted to sorin group usa for review.Sorin was informed that the guidewire would not be available for return.The catalog number identified in the customer medwatch report is for a cannula kit that does not contain a guidewire.Shipment history found that only two catalog numbers ordered by this facility contain guidewires.One sample from each catalog number was pulled to be compared with the customer photograph.The customer photo shows that the guidewire removed from the patient was a bright green color, whereas the guidewires offered by sorin are dark green.The wire in the photograph is unraveled, stretched out and bent, and so the exact length cannot be determined.However, using the scale in the photograph, the length of the removed guidewire is estimated to be between 45 - 60 cm.The two types of guidewires that were shipped to this hospital by sorin are 100cm and 180cm in length.Based on the information provided by the customer, it cannot be determined if the complained guidewire is a sorin group product.A lot number was not provided by the customer, and so a dhr review could not be performed.No product defect was identified, and there is no trend for this type of issue.Sorin group will continue to monitor for trends related to this type of issue.Customer will not return device.

• Brand Name: RAP FEMORAL VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 w. 65th way; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP USA; 14401 w. 65th way; arvada CO 80004
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5683992
• MDR Text Key: 46060967
• Report Number: 1718850-2016-00284
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

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 Catalogue Number: 200-150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 05/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 107