MAUDE Adverse Event Report: PENDRACARE INTERNATIONAL B.V. CONVEY; GUIDING CATHETER

Model Number H749392287380

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Missing Value Reason (3192)

Patient Problem Death (1802)

Event Date 10/12/2015

Event Type  Death  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

It was reported that the patient died.The target lesion was located in the proximal right coronary artery (rca) and proximal to mid left anterior descending artery (lad).A 5f convey guide catheter rbr3 was placed and a 2.25x15mm emerge balloon catheter was advanced for pre dilatation of the lesion.Then a 2.50 mm synergy stent was implanted in the rca without complications.Post dilatation was performed using a 15 mm x 2.50 mm nc quantum apex balloon catheter.The recently implanted stent was patent with no dissections noted.A fractional flow reserve (ffr) assessment was then performed in the proximal to mid lad and the lesion was pre dilated using a balloon catheter.An attempt was made to deploy a 2.50 mm x 32 mm synergy stent, however, the patient became restless and was noted to have electrocardiogram (ecg) changes in the inferior lead.The 2.50 mm x 32 mm synergy stent was able to be deployed in the lad and all access to the lad was removed.Angiography of the rca was performed and revealed that the rca was blocked.A guide wire was then placed in the rca and dilatation was performed using a 2.0 mm balloon catheter to open the vessel.Another fluoroscopy was taken and revealed that the implanted 2.50 mm x 20 mm synergy was patent and was well opposed to the wall however a lot of clots were still noted distal to the 2.50 mm x 20 mm synergy stent.Another 20 mm x 2.25 mm synergy stent was then implanted in the rca.The blood flow was restored however normal sinus rhythm was not regained.Cardiopulmonary resuscitation was performed however the patient died on the same day.

• Brand Name: CONVEY
• Type of Device: GUIDING CATHETER
• Manufacturer (Section D): PENDRACARE INTERNATIONAL B.V.; van der waalspark 22; leek, 9351 VC; NL 9351 VC
• Manufacturer (Section G): PENDRACARE INTERNATIONAL B.V.; van der waalspark 22; leek, 9351 VC; NL 9351 VC
• Manufacturer Contact: jean fischer ; one scimed place a395; mapple grove, MN 15531 ; 7634942228
• MDR Report Key: 5993497
• MDR Text Key: 56191765
• Report Number: 0000000-2016-00001
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729798545
• UDI-Public: 08714729798545
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: 120585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/15/2015,09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: H749392287380
• Device Catalogue Number: H749392287380
• Device Lot Number: 14100142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/13/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2015
• Date Manufacturer Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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
• Treatment: CONVEY GUIDING CATHETER; SYNERGY STENT
• Patient Outcome(s): Death