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

Catalog Number 400SMTXSFT0304

Device Problems Difficult or Delayed Positioning (1157); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was separated on the proximal end of the penumbra smart coil (smart coil) pusher assembly.The pusher assembly was bent along its length.The pusher assembly was delaminated over a 10 cm region from approximately 171.0 cm to 181.0 cm from the proximal end of the pusher assembly.Conclusions: evaluation of the returned smart coil pusher assembly revealed a delaminated and bent pusher assembly.These varied bends in the pusher assembly may be due to being used inside tortuous patient anatomy or may have been incidental during packaging for return to penumbra.Repeated manipulation of the smart coil within tortuous anatomy may cause friction between pusher and microcatheter lumen, which may cause the pusher to become delaminated.The detachment handle mentioned in the case was not returned for evaluation and, therefore, the root cause of the difficulty detaching this coil and reported ¿dull noise¿ when actuated could not be determined.The embolization coil was implanted and, therefore, was not available to be returned for evaluation.Since the non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.The foreign object reportedly blocking the catheter could not be investigated or confirmed.Penumbra coils and handles 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: 3005168196-2017-02303.

Event Description

The patient was undergoing a coil embolization procedure in the left internal carotid (ica) artery using penumbra smart coils (smart coils) and penumbra smart coil detachment handle (handle).During the procedure, the physician placed two smart coils in the target vessel using a non-penumbra microcatheter.The physician then advanced a new smart coil in the aneurysm and attempted to detach it using a handle; however, a dull sound was heard when pulling on the lever of the handle and the smart coil was not detached.The physician then made several attempts to detach the smart coil; however, the coil would not detach.Therefore, the physician decided to retract the handle from the smart coil pusher assembly; however, the handle remained stuck to the smart coil pusher assembly.Thus, the physician forcefully pulled the handle then noticed that the smart coil was pulled out of the aneurysm approximately two centimeters.Therefore, the physician re-advanced the smart coil into the aneurysm and manually pulled the pull wire to detach the smart coil in the aneurysm.While attempting to advance a new smart coil through the microcatheter, the smart coil became entrapped half way through the microcatheter.Therefore, the microcatheter containing the smart coil was removed from the patient¿s body.The physician was then unable to flush microcatheter.It was reported that something was stuck inside the microcatheter and that the guidewire would not advance pass the same position in the microcatheter.Therefore, the procedure was completed using the same smart coil, the same handle and a new 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: 7154963
• MDR Text Key: 96111999
• Report Number: 3005168196-2017-02302
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015347
• UDI-Public: 00814548015347
• 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: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/06/2021
• Device Catalogue Number: 400SMTXSFT0304
• Device Lot Number: F73041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2016
• 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