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

Catalog Number	400SMTXSFT0408
Medical Device Problem Codes	Out-Of-Box Failure (2311); Defective Device (2588); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: there was no secondary shape to the embolization coil upon the initial advancement of the penumbra smart coils (smart coils) out of their introducer sheaths.After lightly shaking the embolization coils, the coils relaxed and the secondary shapes were present.Conclusions: evaluation of the returned devices revealed that the smart coils'' secondary shape was not present after the initial advancement out of their introducer sheaths.After lightly shaking the embolization coils once they were removed from their sheaths, the coils relaxed and the secondary shapes were present.The root cause of the reported issue may have been related to excess tension within the embolization coils; however, once the tension was released, the coils functioned as intended.Further evaluation revealed the pusher assembly of one of the smart coils was kinked.This damage was likely incidental and may have occurred during packaging for return to penumbra.Penumbra coils are visually inspected for multiple outputs, including secondary shape, 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 numbers: 3005168196-2017-00527, 3005168196-2017-00528, 3005168196-2017-00530.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior-communicating (a-comm) artery using penumbra smart coils (smart coils).During the procedure, while attempting to frame the aneurysm with a smart coil, the physician noticed that the coil was not taking its complex shape inside the patient.Therefore, the smart coil was removed.The physician did not mention any resistance while advancing or retracting the smart coil.The physician then tested three additional smart coils in a bowl of saline on the back table to see if they would form their complex shapes; however, all three coils did not form their intended complex shape.Thereafter, the procedure was completed using the same non-penumbra microcatheter and additional coils.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6465627
• Report Number: 3005168196-2017-00529
• Device Sequence Number: 477070
• Product Code: HCG
• UDI-Device Identifier: 00814548015392
• UDI-Public: 00814548015392
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2017

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
• Operator of Device: Physician
• Device Expiration Date: 10/19/2021
• Device Catalogue Number: 400SMTXSFT0408
• Device Lot Number: F72377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2017
• Initial Report FDA Received Date: 04/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1