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

Catalog Number	400SMTSFT0615
Medical Device Problem Codes	Kinked (1339); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 28.0, 46.0, and 134.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.The outer diameter (od) of the pusher assembly mid-joint was measured to be within specification.Conclusions: evaluation of the returned smart coil revealed that the coil could be advanced within its introducer sheath with some resistance.During the functional test, resistance was encountered while advancing the smart coil from its initial position; however, the smart coil was able to be advanced from its initial position.The smart coil was then attempted to be advance through a demonstration microcatheter; however, the introducer sheath could not be retracted over the pusher assembly kink.Therefore, the smart coil was unable to be advanced through the demonstration microcatheter.The od of the pusher assembly mid-joint was measured and found to be within specification.The introducer sheath could not be removed from the pusher assembly and therefore, the id could not be measured.The root cause of the reported resistance could not be determined.Penumbra coils are visually 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 to treat a renal benign lipoma using penumbra smart coils (smart coils).During the procedure, while attempting to insert a smart coil into the hub of a non-penumbra microcatheter, the physician experienced resistance at the initial push and the smart coil pusher assembly would not advance at all.Subsequently, the smart coil pusher assembly became kinked; therefore, the smart coil was removed.The procedure was completed using two other smart 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: 7648949
• Report Number: 3005168196-2018-01281
• Device Sequence Number: 16531604
• Product Code: HCG
• UDI-Device Identifier: 00814548014975
• UDI-Public: 00814548014975
• 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): 05/30/2018

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: 10/24/2022
• Device Catalogue Number: 400SMTSFT0615
• Device Lot Number: F80176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR