PENUMBRA SYSTEM REPERFUSION CATHETER 054

Report

Report Number: 3005168196-2013-00025
Event Type: Injury
Date Received: January 11, 2013
Date of Event: December 6, 2012
Report Date: December 12, 2012
Manufacturer: PENUMBRA, INC.
Product Code: NRY
PMA / PMN Number: K090752
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCLUSION: HEMORRHAGE IS A KNOWN AND ANTICIPATED COMPLICATION ASSOCIATED WITH THESE TYPES OF PROCEDURES AND IS NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS. DISCARDED BY THE HOSPITAL.

Description of Event or Problem · 1

THE PATIENT WAS UNDERGOING TREATMENT FOR ACUTE CEREBRAL INFARCTION. A MICRO GUIDE WIRE WAS PLACED IN THE MCA (M2) AND THE PSC032 WAS INTRODUCED TOWARD THE PERIPHERAL BRANCH OF THE MCA BUT STOPPED AT THE ORIGIN OF THE MCA. THE PHYSICIAN ADVANCED THE PSC054 INTO THE PERIPHERAL BRANCH OF THE ICA HAVING A BALLOON CATHETER (OPTIMO 9FR) INFLATED IN ATTEMPT TO IMPROVE STENOSIS FOUND IN THE C1-TOP AND MOVED THE PSC032 IN-AND-OUT. AFTER THESE MOTIONS, EXTRAVASATION IN THE ICA (C1) WAS CONFIRMED WITH ANGIOGRAPHY. HEPARIN REVERSAL WAS PERFORMED AND A BALLOON WAS USED TO ARREST THE HEMORRHAGE WITH SUCCESS AND THE PROCEDURE WAS CONCLUDED. PHYSICIAN'S COMMENT: THE PSC032 MOVED BACK AND FORTH BETWEEN THE C2 AND THE M1, AND THE PSC054 LIKEWISE BETWEEN C3 AND C1. EXTRAVASATION IS QUESTIONED TO HAVE COME ABOUT IN THESE MOTIONS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2013-00024.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
16351	PENUMBRA SYSTEM REPERFUSION CATHETER 054	NRY	NRY	PENUMBRA, INC.		F25802

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Required Intervention