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

Model Number	400SMTXSFT3H06
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2017
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: 3005168196-2017-01993; 3005168196-2017-01994; 3005168196-2017-01995; 3005168196-2017-01996.The hospital discarded the device.
Event or Problem Description
The patient was undergoing coil embolization procedure to treat a subarachnoid hemorrhage using penumbra smart coils (smart coils).During the procedure, the physician was unable to advance a smart coil out its introducer sheath and into a non-penumbra microcatheter; therefore, it was removed.It was reported that the same issue was encountered with four additional smart coils.The procedure was completed using five other smart coils, a non-penumbra coil and the same microcatheter.There was no report of adverse effect to the patient.
Additional Manufacturer Narrative
This report is associated with mfr report numbers: 3005168196-2017-01993, 3005168196-2017-01994, 3005168196-2017-01995, 3005168196-2017-01996.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7023152
• Report Number: 3005168196-2017-01992
• Device Sequence Number: 156104
• Product Code: HCG
• UDI-Device Identifier: 00814548017112
• UDI-Public: 00814548017112
• 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): 10/17/2017
• 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: 01/30/2022
• Device Model Number: 400SMTXSFT3H06
• Device Catalogue Number: 400SMTXSFT3H06
• Device Lot Number: F74097
• 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: 10/17/2017
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Date Report Sent to FDA: 01/01/2005