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

Catalog Number	400SMTXSFT0203
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The coil was implanted into the patient; however, the pusher assembly is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2017-00661.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the cerebral artery using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician deployed and detached three smart coils into the target vessel using a non-penumbra microcatheter and the handle.The physician then had difficulty detaching a fourth smart coil but was able to detach the coil after multiple manipulation attempts using the same handle.A fifth smart coil was deployed into the target vessel and an attempt was made to detach the coil using the same handle.However, the physician was unable to detach the coil even after manipulation.Subsequently, the proximal end of the pusher assembly became fractured.Therefore, the physician manually detached the smart coil using forceps and successfully completed the procedure using additional coils and a new handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the penumbra smart coil (smart coil) pusher assembly was folded and wrapped around itself upon receiving.The pull wire was found to be retracted and the pet lock was broken.The pusher assembly was fractured approximately 5.0 cm from the proximal end.The smart coil was implanted in the patient and therefore, could not be functionally tested.Conclusions: evaluation of the device revealed that the pet lock was broken and the pusher assembly was fractured on its proximal end.The pet lock was likely broken during the initial attempt to detach the coil with the handle.The fracture damage was likely a result of the physician reportedly folding the pusher in attempt to manually detach the coil.Further evaluation revealed extensive pusher damage.This damage is likely a result of the device being folded and wrapped up in itself for return to penumbra facilities.The handle was tested on calibrated fixture and was able to provide sufficient pull force and throw distance.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.Penumbra coils and handles 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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6538536
• Report Number: 3005168196-2017-00662
• Device Sequence Number: 1345175
• Product Code: HCG
• UDI-Device Identifier: 00814548015279
• UDI-Public: 00814548015279
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2017

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: 07/28/2021
• Device Catalogue Number: 400SMTXSFT0203
• Device Lot Number: F70876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR