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

Catalog Number 400SMTXSFT0204

Device Problems Bent (1059); Failure to Advance (2524); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the second smart coil¿s pusher assembly.The distal region of the pusher assembly was deformed.The embolization coil was intact with the pusher assembly and had offset coil winds and gaps near its proximal end.Conclusions: evaluation of the first smart coil revealed the embolization coil was detached from the pusher assembly.Since the smart coil was reportedly removed from the procedure without detachment issues, this detachment was likely incidental and likely occurred after successful removal of the smart coil.Since the first smart coil was detached and the embolization coil was not returned for evaluation, the root cause of the resistance experienced when advancing the first smart coil could not be determined.Evaluation of the second smart coil revealed the embolization coil had offset coil winds and gaps near its proximal end.If the smart coil is forcefully advanced while the introducer sheath is not properly aligned inside the hub, resistance may be experienced, and damage such as this may occur.This damage likely contributed to the resistance when advancing the smart coil during functional analysis.Further evaluation revealed the distal regions of both pusher assembly were deformed.This damage may have occurred due to forceful advancement of the smart coil against resistance.The non-penumbra microcatheter mentioned in the complaint and the first smart coil¿s embolization coil were not returned for evaluation.Penumbra coils are 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.This report is associated with mfr report number: 3005168196-2017-00749.

Event Description

The patient was undergoing a coil embolization procedure in the anterior communicating artery using penumbra smart coils (smart coils).During the procedure, while attempting to advance a smart coil through a non-penumbra microcatheter, the physician experienced resistance and was unable to advance the smart coil.Consequently, the smart coil pusher assembly became bent and therefore, it was removed.The physician then attempted to advance a new smart coil through the microcatheter; however, resistance was experienced again, the smart coil was unable to advance and the pusher assembly was bent.The smart coil was removed and the procedure was completed using the same microcatheter and additional smart coils.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: 6576147
• MDR Text Key: 75528372
• Report Number: 3005168196-2017-00750
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015286
• UDI-Public: 00814548015286
• 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: Physician
• Type of Report: Initial
• Report Date: 04/19/2017

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: 11/01/2021
• Device Catalogue Number: 400SMTXSFT0204
• Device Lot Number: F72604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2016
• 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