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

Catalog Number	400SMTXSFT0205
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the smart coil pusher assembly was kinked in multiple locations along its length.A length of the distal polymer section was delaminated from approximately 171.0 ¿ 182.0 cm from the proximal end (figure 2).Pet material can be seen bunched up on the distal end of the delaminated section and was measured with a snap gauge to be approximately 0.019¿.Conclusions: evaluation of the returned smart coil pusher assembly revealed delamination on the distal polymer section of the pusher assembly.This damage can occur if the pusher assembly is retracted against strong resistance.The root cause of the resistance was likely a result of retracting the device through a kinked and ovalized non-penumbra microcatheter.The subsequent bunching up of the delaminated pet material likely contributed to additional resistance.Further evaluation revealed kinks along the length of the pusher assembly.These kinks were likely incidental and occurred during packaging for return to penumbra.If any of these kinks were present during the procedure, they would likely have contributed to the resistance experienced also.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 anterior communicating artery (aca) using penumbra smart coils (smart coils).During the procedure the physician successfully placed a coil in the target vessel using a non-penumbra microcatheter; however, wile removing the smart coil pusher assembly, the physician experienced resistance after removing approximately half of the smart coil pusher assembly.Subsequently, the smart coil pusher assembly became stuck inside the microcatheter.Therefore, the physician removed the microcatheter and smart coil pusher assembly together, and completed the procedure using another microcatheter and additional 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: 7587756
• Report Number: 3005168196-2018-01154
• Device Sequence Number: 1754755
• Product Code: HCG
• UDI-Device Identifier: 00814548015293
• UDI-Public: 00814548015293
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2018

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: 12/18/2021
• Device Catalogue Number: 400SMTXSFT0205
• Device Lot Number: F73222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR