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

Model Number	400SMTXSFT0410
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2020-01318, 3005168196-2020-01319, 3005168196-2020-01320.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician placed and detached a smart coil into the target vessel using the handle.The physician then placed another smart coil into the tip of the aneurysm and attempted to detach it using the handle; however, after two attempts, the smart coil failed to detach.It was reported that the physician depressed the handle and pulled it back before hearing an audible click; but the smart coil did not detach.Then, the physician manually pulled apart the microcatheter to pull the pusher assembly of the smart coil to detach it; however, the smart coil did not detach.Therefore, the smart coil and handle were removed.Next, the physician placed and detached multiple smart coils into the target vessel using a new handle.While advancing two additional smart coils, the physician experienced resistance within its introducer sheath.However, the physician was able to successfully place and detached both smart coils into the aneurysm.The procedure was completed using additional smart coils, the same second handle, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of its pusher assembly.The pull wire was retracted out of the distal detachment tip (ddt), and the embolization coil was detached from its pusher assembly.Coagulated blood was present inside the ddt.Conclusions: evaluation of the returned smart coil revealed a broken pet lock and a detached embolization coil.If the pet lock is broken and the pull wire is retracted out of the ddt, the embolization coil will detach from its pusher assembly.The detached embolization coil was not returned for evaluation.Based on the returned condition, the root cause of the reported complaint could not be determined.Evaluation of the returned handle revealed a functional device.During the functional test, the handle was tested on the handle test fixture and passed within specification.The handle was then used to detach a demonstration smart coil without an issue.Penumbra coils and the handles 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: 1.3005168196-2020-01318, 2.3005168196-2020-01319, 3.3005168196-2020-01320.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10467125
• Report Number: 3005168196-2020-01317
• Device Sequence Number: 3001446
• Product Code: HCG
• UDI-Device Identifier: 00814548015408
• UDI-Public: 00814548015408
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 08/03/2020
• 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: 07/15/2024
• Device Model Number: 400SMTXSFT0410
• Device Catalogue Number: 400SMTXSFT0410
• Device Lot Number: F91797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 10/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Date Report Sent to FDA: 01/01/2005