MAUDE Adverse Event Report: PERFUSION SYSTEMS ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 87022

Device Problems Material Puncture/Hole (1504); Insufficient Information (3190)

Patient Problem Thrombus (2101)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of the dlp curved tip arterial cannula, it was noted that there was blood seen between the cannula and the wirewound.The leak was not noted until the end of the procedure, so the cannula was not replaced.The patient had a thrombus-embolism.

Manufacturer Narrative

Visual analysis: visual inspection shows evidence of blood inside the returned device.Evidence of blood residue in between the walls of the device, inside the layer with the wire.There is evidence of a hole/tear in the outer wall of the device.Performance analysis: during the cleaning process there was a leak observed from the hole/tear.Additional information; date of birth provided, date of event updated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARTERIAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8178158
• MDR Text Key: 130769726
• Report Number: 2184009-2018-00048
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K840002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 87022
• Device Catalogue Number: 87022
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 01/10/2019
• Supplement Dates FDA Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization
• Patient Age: 57 YR