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

Model Number	400SMTXSFT0102
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
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 number: 3005168196-2021-00434.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the iliolumbar artery using penumbra smart coils (smart coils), non-penumbra coils, and a non-penumbra microcatheter.It was noted that the patient anatomy was tortuous.During the procedure, the physician placed three smart coils in the target vessel using a microcatheter.While attempting to advance the next smart coil, the physician was unable to advance it beyond the hub of the microcatheter.Therefore, the smart coil was removed.Afterwards, the physician placed another smart coil in the target vessel using the microcatheter.While advancing the next smart coil through the microcatheter, the smart coil became stuck in the middle of the microcatheter.Therefore, the smart coil was removed.It was also reported that the physician attempted to advance a non-penumbra coil through the microcatheter but was unable to and therefore, it was removed.The procedure was completed using three other coils and the same microcatheter.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: 11437230
• Report Number: 3005168196-2021-00435
• Device Sequence Number: 11542535
• Product Code: HCG
• UDI-Device Identifier: 00814548015187
• UDI-Public: 00814548015187
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2021
• 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: 11/01/2021
• Device Model Number: 400SMTXSFT0102
• Device Catalogue Number: 400SMTXSFT0102
• Device Lot Number: F72607
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2021
• Initial Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Date Report Sent to FDA: 01/01/2005