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

Catalog Number	400SMTHXSFT0410
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	01/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra smart coil (smart coil) pusher assembly.The pusher assembly was kinked approximately 45.0, 65.0, and 131.0 cm from the proximal end.The embolization coil was intact with its pusher assembly and the coil winds were offset.Conclusions: evaluation of the returned device revealed that the smart coil embolization coil winds were offset and the pusher assembly was kinked.The offset coil winds typically occur due to improper handling during use.If the introducer sheath is not properly aligned inside the hub of the microcatheter prior to advancement, damage such as this may occur.Further evaluation of the returned device revealed that the pusher assembly was kinked.This type of damage likely occurred due to forceful advancement against resistance, while attempting to advance the smart coil through the non-penumbra microcatheter during the procedure.The offset coil winds likely caused the friction experienced while attempting to advance the smart coil through the non-penumbra microcatheter.The smart coil was attempted to be advanced through a demonstration microcatheter.While advancing the smart coil through the introducer sheath; resistance was encountered as the kink in the pusher assembly was advanced through the introducer sheath and the smart coil could not be advanced any further.The non-penumbra microcatheters referred to in the complaint were not returned 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.This report is associated with mfr report numbers: 3005168196-2018-00279; 3005168196-2018-00280.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) to treat an unruptured aneurysm using penumbra smart coils (smart coils).During the procedure, while attempting to load three smart coils through the hub of two different non-penumbra microcatheters, the physician experienced friction.The smart coils were able to be advanced to the distal tip of the their introducer sheaths but would not advance completely out of the sheaths and into the microcatheters.Therefore, the smart coils were removed and the procedure was successfully completed using two new smart coils, additional coils and the second 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: 7242806
• Report Number: 3005168196-2018-00278
• Device Sequence Number: 1222713
• Product Code: HCG
• UDI-Device Identifier: 00814548015835
• UDI-Public: 00814548015835
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2018

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: 12/14/2021
• Device Catalogue Number: 400SMTHXSFT0410
• Device Lot Number: F73171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1