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

Catalog Number	400SMTSFT0820
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2018
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 fractured approximately 137.5 cm from the proximal end.The pull wire was completely retracted out of the pusher assembly and the embolization coil was detached from its pusher assembly inside its introducer sheath.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly was fractured.If the device is forcefully advanced against resistance, damage such as a kink may occur.Subsequently, if the kinked device is further manipulated, the kink may worsen and fracture.The root cause of the initial resistance could not be determined.The non-penumbra microcatheter identified in the complaint was not returned to penumbra for evaluation.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 in the abdominal aorta using penumbra smart coils (smart coils).During the procedure, while attempting to advance a smart coil into the hub of a non-penumbra microcatheter, the physician experienced resistance at the distal tip of the introducer sheath and coil would not advance out of the introducer sheath; therefore, it was removed.It was also reported that the physician accidentally kinked the smart coil pusher assembly.The procedure was completed using another smart coil, ruby coils, 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: 7793696
• Report Number: 3005168196-2018-01620
• Device Sequence Number: 1195566
• Product Code: HCG
• UDI-Device Identifier: 00814548014753
• UDI-Public: 00814548014753
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2018
• 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: 02/06/2023
• Device Catalogue Number: 400SMTSFT0820
• Device Lot Number: F81796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• 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: 07/19/2018
• Initial Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005