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

Catalog Number	400SMTHXSFT0410
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-01523.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the iliolumbar artery using penumbra smart coils (smart coils).During the procedure, a smart coil would not advance beyond its introducer sheath; therefore, it was removed.It was reported that the same issue occurred with another smart coil.Therefore, it was also removed.The procedure was completed using additional smart coils.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 penumbra smart coil (smart coil) pusher assembly.The pusher assembly was kinked approximately 44.0, 101.5 and 133.0 cm from the proximal end.The pusher assembly mid-joint was distal to the introducer sheath friction lock.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).Offset coil winds were present on the proximal end of the embolization coil.Conclusions: evaluation of the two returned smart coils revealed offset coil winds on the proximal ends of their embolization coils.This type of damage typically occurs if the introducer sheath is not aligned properly within the hub of a parent catheter.If this occurs, the embolization coil may begin to take shape within the hub of the microcatheter and resistance may be experienced during advancement of the smart coils.If the smart coil is forcefully advanced against resistance, damage such as offset coil winds may occur.During functional testing of the first returned smart coil, resistance was experienced while attempting to advance the smart coil within its introducer sheath and the smart coil could not advance at all.During functional testing of the second returned smart coil, the smart coil was advanced out of its introducer sheath with resistance.While attempting to advance the smart coil through a demonstration microcatheter, resistance was experienced at the hub as the embolization coil began to take shape within the hub and the smart coil could not advance any further.The offset coil winds likely contributed to the resistance experienced during functional testing of both smart coils.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.This report is associated with mfr report number: 3005168196-2019-01523 h3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8864371
• Report Number: 3005168196-2019-01522
• Device Sequence Number: 2390393
• Product Code: HCG
• UDI-Device Identifier: 00814548015835
• UDI-Public: 00814548015835
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 07/08/2019
• 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: 12/25/2023
• Device Catalogue Number: 400SMTHXSFT0410
• Device Lot Number: F87662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 95
• Date Report Sent to FDA: 01/01/2005