FDA Adverse Event Injury Summary report: N

PENUMBRA SYSTEM REPERFUSION CATHETER 032

MDR report key: 2041899 · Received March 30, 2011

Report

Report Number: 3005168196-2011-00132
Event Type: Injury
Date Received: March 30, 2011
Date of Event: February 26, 2011
Report Date: March 1, 2011
Manufacturer: PENUMBRA, INC.
Product Code: NRY
PMA / PMN Number: K072718
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCLUSION: VESSEL DISSECTION OR PERFORATION IS A KNOWN AND ANTICIPATED COMPLICATION WITH THIS TYPE OF PROCEDURE AND IS NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

Description of Event or Problem · 1

THE PT HAD A DISTAL M1 OCCLUSION. THE PHYSICIAN USED THE PENUMBRA SYSTEM REPERFUSION CATHETER 054 OVER THE PENUMBRA SYSTEM REPERFUSION CATHETER 032 TO PUT THE 054 CATHETER IN THE DISTAL M1. THE PHYSICIAN PULLED THE 032 CATHETER OUT AND INTRODUCED THE PENUMBRA SYSTEM SEPARATOR 054. THE PHYSICIAN USED THE SEPARATOR AND SAID THE SEPARATOR MOVED VERY SMOOTHLY AND DID NOT APPEAR TO GO IN TO ANY PERIPHERAL VESSELS. HE CLEARED THE CLOT AND DID AN ANGIOGRAM AND NOTICED A SMALL AMOUNT OF CONTRAST OUTSIDE THE VESSEL. THE PHYSICIAN EXPLAINED THAT THE PT'S VESSELS WERE VERY DISEASED DUE TO CHRONIC COCAINE USAGE AND IT IS UNK IF THE CONTRAST EXTRAVASATION WAS DUE TO LEAKY VESSELS BECAUSE OF THE DISEASE STATE, OR IF THERE WAS ANY TRUE VESSEL INJURY DURING REPERFUSION. THE PHYSICIAN MENTIONED THAT HE DID NOT THINK THE INJURY WAS DUE TO THE PRODUCT. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2011-00130 AND MDR 3005168196-2011-00133.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PENUMBRA SYSTEM REPERFUSION CATHETER 032		NRY	PENUMBRA, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other