MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Catalog Number 400SMTHXSFT0208

Device Problems Failure to Advance (2524); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked in multiple locations.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the returned smart coil revealed that the device was able to be advanced through a microcatheter with some resistance.During the functional test, resistance was encountered during the initial attempt to advance the smart coil from its returned position, and as the kinks in the pusher assembly were advanced through its introducer sheath and demonstration microcatheter.However, the smart coil was advanced completely through the microcatheter and out of the distal tip.The id of the introducer sheath and od of the pusher assembly mid-joint were measured and found to be within specification.The root cause of the reported resistance could not be determined.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a coil embolization procedure to treat a dural arteriovenous fistula using penumbra smart coils (smart coils).During the procedure, the physician successfully placed two coils using a non-penumbra microcatheter.The physician then experienced resistance and was unable to advance a smart coil out of its introducer sheath and into the hub of the microcatheter.The smart coil was therefore removed, and the procedure was then completed using 13 smart coils, 21 other coils, and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7660411
• MDR Text Key: 113270060
• Report Number: 3005168196-2018-01330
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015996
• UDI-Public: 00814548015996
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/29/2022
• Device Catalogue Number: 400SMTHXSFT0208
• Device Lot Number: F78966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2017
• 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
• Patient Age: 70 YR