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

Catalog Number	400SMTSFT0820
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the returned penumbra smart coil (smart coil) was kinked along the length of its pusher assembly.There was an unknown substance on the length of the distal detachment tip (ddt).The embolization coil was compressed on its proximal end.Conclusions: evaluation of the returned smart coil revealed the embolization coil was compressed on its proximal end.These damages were likely due to forceful manipulation against resistance.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation and, therefore, the cause of the resistance could not be determined.Further evaluation revealed a foreign substance on the ddt and proximal end of the embolization coil.The origin of the substance is unknown but may have contributed to resistance experienced during the procedure.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroepiploic artery using penumbra smart coils (smart coils).During the procedure, the physician placed five smart coils in the target vessel using a non-penumbra microcatheter.While attempting to advance a new smart coil through the microcatheter, the physician experienced resistance and the smart coil would not advance out of the microcatheter; therefore, it was removed.The procedure was completed using additional smart coils and the same microcatheter without further issues.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: 7186562
• Report Number: 3005168196-2018-00114
• Device Sequence Number: 19194401
• Product Code: HCG
• UDI-Device Identifier: 00814548014753
• UDI-Public: 00814548014753
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2017

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: 06/04/2022
• Device Catalogue Number: 400SMTSFT0820
• Device Lot Number: F77494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1