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

Catalog Number	400SMTXSFT2H08
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage, Subarachnoid (1893); Rupture (2208)
Date of Event	10/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The coil was implanted.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery using penumbra smart coils (smart coil) to treat an aneurysm that had formed off an aneurysm clipping done on the patient years prior.During the procedure, the physician placed another manufacturer's intracranial support catheter, balloon catheter, and microcatheter, then advanced a smart coil through the other manufacturer's microcatheter.While attempting to position the smart coil in the aneurysm, the physician felt that the microcatheter and smart coil ¿jumped¿ as the second loop of the smart coil was out of the microcatheter.Consequently, the aneurysm was perforated by the microcatheter and smart coil.The physician used the smart coil to fill the ruptured aneurysm.The procedure was completed using the same microcatheter and two additional smart coils.An external ventricular drain was placed at the end of the procedure.It should be noted that the physician used a rotating hemostasis valve (rhv) and maintained continuous flush in the procedure.A follow up computed tomography (ct) preformed on (b)(6) 2016 demonstrated subarachnoid hemorrhage (sah) and a small volume intrapenchymal hemorrhage secondary to aneurysmal rupture.The patient was managed with supportive treatment and medications.The subarachnoid hemorrhage (sah) was reported to have a definite relationship to the aneurysm, angiographic procedure and smart coil.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2016-01585.1.Section g.Box 3.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6091393
• Report Number: 3005168196-2016-01585
• Device Sequence Number: 18923424
• Product Code: HCG
• UDI-Device Identifier: 00814548015576
• UDI-Public: 00814548015576
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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): 10/12/2016
• 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?: No
• Operator of Device: Physician
• Device Expiration Date: 01/09/2021
• Device Catalogue Number: 400SMTXSFT2H08
• Device Lot Number: F67443
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/12/2016
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 11/09/2016
• Supplement Report FDA Received Date: 06/03/2019
• 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: Other
• Patient Age: 53 YR
• Date Report Sent to FDA: 01/01/2005