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

Catalog Number	400SMTSTD1460
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2017
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: 3005168196-2017-02247, 3005168196-2017-02248, 3005168196-2017-02250.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the ascending aorta using penumbra smart coils (smart coils).During the procedure, the physician successfully deployed and detached five smart coils using a non-penumbra microcatheter, but also felt resistance advancing four smart coils out of the microcatheter and into the patient.It was reported that the physician was having difficulty seeing when the smart coils exited the microcatheter, and therefore the physician was unsure whether the resistance was caused by the microcatheter positioning, a possible kink in the microcatheter, or whether the resistance was due to the smart coils.The four smart coils were therefore retracted, and the procedure was continued using shorter smart coils.The procedure was then completed using a lantern delivery microcatheter and ruby coils.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7131160
• Report Number: 3005168196-2017-02249
• Device Sequence Number: 1916312
• Product Code: HCG
• UDI-Device Identifier: 00814548014289
• UDI-Public: 00814548014289
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

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: 02/23/2022
• Device Catalogue Number: 400SMTSTD1460
• Device Lot Number: F74599
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR