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

Model Number	400SMTXSFT0304
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2020-01663, 3005168196-2020-01664, 3005168196-2020-01665.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right middle cerebral artery (mca) using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, the angiogram revealed that the smart coil went through the blister of the aneurysm and ruptured it.However, the smart coil was still implanted and the physician continued to implant coils to stop the bleed.It was also reported that another smart coil would not advance past the hub of the microcatheter and was therefore removed.While attempting to advance two more smart coils, they would not advance from their initial positions within their respective introducer sheaths.Therefore, these two smart coils were also removed.The procedure was completed using other smart coils and the same microcatheter.It was reported that the patient is stable.
Additional Manufacturer Narrative
Evaluation of the first returned smart coil pusher assembly confirmed that the coil was detached from its pusher assembly.The complaint stated that the embolization coil was implanted in the patient.There is no evidence of a malfunction of this device.Evaluation of the second returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.During the functional test, the pusher assembly mid-joint was able to advance through the introducer sheath friction lock with resistance when using proper technique.Resistance was then encountered, and the embolization coil could not be advanced out of its introducer sheath.Evaluation of the third returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction.If this occurs, resistance may be experienced during advancement.During the functional test, resistance was encountered while attempting to advance the pusher assembly mid-joint through the introducer sheath friction lock when using proper technique, and the smart coil could not be advanced at all.Further evaluation revealed that the introducer sheath was stretch along the pusher assembly.This damage may have occurred during troubleshooting attempts during the procedure and likely contributed to the resistance felt during the functional test.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.This report is associated with mfr report numbers: 1.3005168196-2020-01663, 2.3005168196-2020-01664, 3.3005168196-2020-01665.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10671235
• Report Number: 3005168196-2020-01666
• Device Sequence Number: 11445175
• Product Code: HCG
• UDI-Device Identifier: 00814548015347
• UDI-Public: 00814548015347
• Combination Product (Y/N): Y
• 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,Followup
• Report Date (Section B): 09/14/2020
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 01/12/2025
• Device Model Number: 400SMTXSFT0304
• Device Catalogue Number: 400SMTXSFT0304
• Device Lot Number: F95555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 81
• Date Report Sent to FDA: 01/01/2005