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

Catalog Number	400SMTHXSFT0406
Medical Device Problem Codes	Defective Device (2588); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2019
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
During receiving inspection of a penumbra smart coil (smart coil), the smart coil product display box was found to have sustained damage while in transit.However, the physician proceeded to use the smart coil in the procedure.During advancement of the smart coil through the non-penumbra microcatheter, the physician encountered resistance.The smart coil was therefore removed and was no longer used in the procedure.The procedure was completed using another 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 penumbra smart coil (smart coil) pusher assembly.Bends were present along the pusher assembly.The pusher assembly was fractured approximately 138.5 cm from the hub.The pusher assembly mid-joint was positioned proximal to the introducer sheath friction lock.The embolization coil detached from the pusher assembly and was not returned for evaluation.Conclusions: evaluation of the returned smart coil revealed the pusher assembly mid-joint was positioned proximal to the introducer sheath friction lock.If this occurs, resistance may be experienced while advancing the smart coil within the introducer sheath.Further evaluation revealed pusher assembly kinks, a fractured pusher assembly and a detached embolization coil.If the device is forcefully mishandled while advancing against resistance, damage such as a kink may occur.If a kinked device is further manipulated, the kink may worsen to a fracture.If the pusher assembly fractured segments are separated, the pull wire will likely retract out of the pusher assembly distal detachment tip (ddt) and the embolization coil will detach.Further evaluation revealed additional kinks.These damages were likely incidental to the reported complaint and may have occurred during packaging for return to 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.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: 8896809
• Report Number: 3005168196-2019-01596
• Device Sequence Number: 1504939
• Product Code: HCG
• UDI-Device Identifier: 00814548015811
• UDI-Public: 00814548015811
• Combination Product (Y/N): Y
• Initial Reporter Country: PO
• 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): 07/16/2019
• 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: 03/08/2023
• Device Catalogue Number: 400SMTHXSFT0406
• Device Lot Number: F82242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/13/2019
• 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