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

Model Number	400SMTXSFT0104
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure using a penumbra smart coil (smart coil).During the procedure, the smart coil would not advance within its introducer sheath; therefore, it was removed.The procedure was completed using a new smart coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly mid-joint was proximal to the introducer sheath friction lock.The embolization coil was intact with its pusher assembly and had offset coil winds.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced while advancing the device.During the functional test, resistance was encountered while attempting to advance the smart coil through its introducer sheath from its returned position, and the smart coil could not be advanced at all.Therefore, the smart coil was retracted out of its introducer sheath, and the smart coil was re-sheathed properly.Resistance was then encountered due to the offset coil winds inside the introducer sheath and the smart coil could not be advance out of its introducer sheath at all.These offset coil winds on the embolization coil were likely incidental to the complaint.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10228421
• Report Number: 3005168196-2020-00893
• Device Sequence Number: 16292123
• Product Code: HCG
• UDI-Device Identifier: 00814548015507
• UDI-Public: 00814548015507
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020
• 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: 10/30/2021
• Device Model Number: 400SMTXSFT0104
• Device Catalogue Number: 400SMTXSFT0104
• Device Lot Number: F72557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005