RADI PRESSUREWIRE 4 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-01 for RADI PRESSUREWIRE 4 * manufactured by Radi Medical Systems Ab.

Event Text Entries

[366058] Pt. Undergoing emergent cardiac catheterization. Findings included 40-50% stenosis of left main coronary artery (lmca) at origin and 80% stenosis of the midportion of the circumflex artery (ccx). As ccx was felt to be cause of symptoms, ffr measurements were taken. Instrumentation as listed below. There was a substantial gradient across the ccx lesion and a decision made to stent the lesion. Attempts to place the stent could not pass beyond the midportion of the lesion. On attempting to pull stent back into the guiding catheter, there was resistance. With some pulling, the stent was pulled about 20 cm. Back into the guiding catheter over the radi wire but could not be retrieved further. After inserting a new bmw wire through the guiding catheter adjacent to the radi wire, and advancing it past the ccx lesion, the radi wire and stent were removed as a unit. Just after this, blood pressure dropped and heart rate slowed. Injection to lmca revealed total lmca occlusion. From this point, patient deteriorated, lmca flow could not be reestablished, and resuscitation failed and the patient expired.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 514228
• MDR Report Key: 514228
• Date Received: 2004-03-01
• Date of Report: 2004-02-27
• Date of Event: 2004-02-05
• Date Facility Aware: 2004-02-19
• Report Date: 2004-02-27
• Date Reported to FDA: 2004-02-27
• Date Reported to Mfgr: 2004-02-27
• Date Added to Maude: 2004-03-05
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: RADI PRESSUREWIRE 4
• Generic Name: 0.014 GUIDEWIRE MOUNTED PRESSURE SENSOR
• Product Code: NQH
• Date Received: 2004-03-01
• Model Number: *
• Catalog Number: *
• Lot Number: 030784
• ID Number: REF 12004
• Device Expiration Date: 2005-01-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 503237
• Manufacturer: RADI MEDICAL SYSTEMS AB
• Manufacturer Address: PALMBLADSGATAN 10 UPPSALA SW SE-754 50

Device Sequence Number: 2

• Brand Name: MULTI-LINK ZETA CORONARY STENT SYSTEM
• Generic Name: STENT, 3.0MM X 38MM
• Product Code: MAF
• Date Received: 2004-03-01
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: REF 1009833-38
• Device Expiration Date: 2005-01-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 2
• Device Event Key: 503239
• Manufacturer: GUIDANT CORP
• Manufacturer Address: * SANTA CLARA CA 950542807 US

Device Sequence Number: 3

• Brand Name: VIKING GUIDING CATHETER
• Generic Name: GUIDING CATHETER JL4, 6F, 0.66" ID
• Product Code: DYB
• Date Received: 2004-03-01
• Model Number: JL4
• Catalog Number: *
• Lot Number: UNK
• ID Number: REF 1001882-06
• Device Expiration Date: 2005-01-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 3
• Device Event Key: 503242
• Manufacturer: GUIDANT/VASCULAR INTERVENTION
• Manufacturer Address: 26531 YNEZ ROAD TEMECULA CA 925914628 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2004-03-01