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

Catalog Number	400SMTXSFT0101
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using a penumbra smart coil (smart coil) and a penumbra smart coil detachment handle (handle).During the procedure, the physician advanced the smart coil into the target vessel using a non-penumbra microcatheter and used the handle to detach it; however, the smart coil failed to detach.The distal end of the smart coil was pulled back into the microcatheter and was re-advanced into the aneurysm.The physician then made a second attempt, but the smart coil did not detach.It was reported that the smart coil pet lock was separated.The smart coil then unintentionally detached while being re-advanced into the aneurysm, but before reaching optimal position.The tail of the smart coil did not hang into the basilar artery but in the aneurysm neck.Some thrombus formation was observed due to additional coil repositioning; however, after lysis and waiting, the thrombus disappeared and showed a good final result.The procedure was ended at this point and there was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was broken and pull tube was retracted at the proximal end of the pusher assembly.The pusher assembly had kinks approximately 4.0 cm, 18.0 cm, 39.0 cm, 53.0 cm, 67.0 cm and 93.0 cm from the proximal end.The distal detachment tip (ddt) was undamaged and had coagulated blood within the distal tip.Conclusions: evaluation of the returned smart coil pusher assembly revealed a retracted pull tube and coagulated blood within the ddt.If there is coagulated blood within the ddt while the pull tube is retracted, the proximal constraint sphere may become stuck disallowing the embolization coil from detaching.This likely contributed to the reported failure to detach.It was reported that the embolization coil detached while re-advancing the smart coil into the target vessel.This manipulation of the smart coil likely assisted in the detachment of the stuck coil.The returned handle was tested using a handle test fixture and performed within specification.Further evaluation revealed bends along the pusher assembly.These kinks were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are 100% visually inspected and functionally tested during incoming quality inspection.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: 3005168196-2019-00072.Device evaluated by mfr: placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8242310
• Report Number: 3005168196-2019-00071
• Device Sequence Number: 2154549
• Product Code: HCG
• UDI-Device Identifier: 00814548015163
• UDI-Public: 00814548015163
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2018
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2023
• Device Catalogue Number: 400SMTXSFT0101
• Device Lot Number: F84117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005