MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC GUIDELINER CATHETER

Model Number 5571

Device Problem Device Damaged by Another Device (2915)

Patient Problem Death (1802)

Event Date 07/13/2017

Event Type  Death  

Manufacturer Narrative

A manufacturing record review was completed and zero nonconformances were found. The returned product evaluation determined that the collar of the catheter had damage consistent with a stent being pushed into it. This happened during the use of the catheter. The event description states that strong resistance was encountered at the transition of the rx lumen. Without receiving the concomitant device for analysis the root cause of the stent not passing through the rx lumen is undeterminable. Attempts were made to obtain patient information, cause including date of death, however, unable to capture this information. (reported that the cause of death is unknown, but it is not due to cardiac event) asku actual date of death.

Event Description

Unable to insert a stent. The patient was in cardiac arrest due to ami, and carried into the operation room while receiving the cardiac massage. Pci was performed with percutaneous cardiopulmonary support (pcps) and intra aortic balloon pumping (iabp). The lesion was #5-6, and pre-dilation of lesion was performed, then a stent (3. 5 mm) was inserted, but it did not pass the lesion. Guideliner was then inserted into the body, and the same stent was inserted; however, the stent got stuck at the transition of half-pipe and rx lumen, and a strong resistance was encountered. A different feeling was felt during guideliner manipulation. A strong resistance was also felt when the stent got stuck at the collar of guideliner. The guideliner was removed and a different catheter was used instead. The same stent could be passed through this catheter and implanted without problems, and the operation was completed. The patient went back to the hospital ward, but passed away later (the cause of death is unknown, but it is not due to cardiac event. ).

• Brand Name: GUIDELINER
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564230
• MDR Report Key: 6791758
• MDR Text Key: 82607566
• Report Number: 2134812-2017-00063
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (Y/N): N
• Reporter Country Code: JA
• PMA/PMN Number: K112082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: DISTRIBUTOR

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/19/2017

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/14/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes

Device Operator

• Device EXPIRATION Date: 11/09/2018
• Device MODEL Number: 5571
• Device LOT Number: 604342
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 11/09/2016
• Is The Device Single Use?: Yes

Is this a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 08/14/2017 Patient Sequence Number: 1