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

Catalog Number	400SMTXSFT4H12
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2017
Type of Reportable Event	Malfunction
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.This report is associated with mfr report numbers: 3005168196-2017-01906, 3005168196-2017-01908, 3005168196-2017-01909, 3005168196-2017-01910.The hospital discarded the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a subarachnoid hemorrhage using penumbra smart coils (smart coils).During the procedure, while attempting to deploy a smart coil into the target vessel using a non-penumbra microcatheter, the physician determined that the coil was too big for the aneurysm and decided to pull it back; however, while retracting the smart coil, resistance was encountered and subsequently, the smart coil unintentionally detached in the microcatheter.Without realizing that the smart coil had unintentionally detached inside the microcatheter, the physician attempted to advance a new smart coil through the microcatheter.However, resistance was encountered and the physician realized that the previous smart coil had unintentionally detached inside the microcatheter; therefore, the new smart coil was removed intact.The microcatheter containing the detached coil was then removed and the coil was flushed out.After that, the microcatheter was reinserted into the patient¿s body.The physician then determined that the smart coil that was previously removed intact was the wrong size prior to reinserting it into the microcatheter and continued the procedure using other smart coils.While attempting to use a new smart coil, the physician had difficulty loading the smart coil into the hub of the microcatheter; therefore, it was removed.It was reported that the same issue occurred with the next three smart coils.The procedure was completed using additional smaller smart coils and the same microcatheter.There was no report of an adverse effect to the patient.
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: 3005168196-2017-01907.1.Section g.Box 3.Report source.This report is associated with mfr report numbers: 1.3005168196-2017-01906, 2.3005168196-2017-01908, 3.3005168196-2017-01909, 4.3005168196-2017-01910 h3 other text : 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: 6988737
• Report Number: 3005168196-2017-01907
• Device Sequence Number: 16443148
• Product Code: HCG
• UDI-Device Identifier: 00814548017204
• UDI-Public: 00814548017204
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 10/04/2017
• 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: Physician
• Device Expiration Date: 11/17/2021
• Device Catalogue Number: 400SMTXSFT4H12
• Device Lot Number: F72146
• 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: 10/04/2017
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Date Report Sent to FDA: 01/01/2005