FDA Adverse Event Malfunction Summary report: N

PENUMBRA SMART COIL DETACHMENT HANDLE

MDR report key: 6772344 · Received August 7, 2017

Report

Report Number: 3005168196-2017-01347
Event Type: Malfunction
Date Received: August 7, 2017
Date of Event: July 3, 2017
Report Date: July 13, 2017
Manufacturer: PENUMBRA, INC.
Product Code: HCG
UDI-DI: 00814548016139
PMA / PMN Number: K160832
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 3005168196-2017-001348, 3005168196-2017-001349. THE HOSPITAL DISPOSED OF THE DEVICE.

Description of Event or Problem · 1

THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OCCIPITAL ARTERY TO TREAT A DURAL ARTERIOVENOUS FISTULA (D-AVF) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED TWO SMART COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER BUT HAD DIFFICULTY DETACHING THE COILS WITH THE HANDLE. IT WAS REPORTED THAT THE ONE OF THE SMART COILS WAS DETACHED AFTER THREE ATTEMPTS AND THE OTHER SMART COIL WAS DETACHED AFTER THE SECOND ATTEMPT. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER, TWO NEW SMART COILS AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
552787	PENUMBRA SMART COIL DETACHMENT HANDLE	HCG, KRD	HCG	PENUMBRA, INC.		F74878	00814548016139

Patients

Seq	Age	Sex	Outcome	Treatment
1