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

Catalog Number	400SMTXSFT011H
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2016
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.This report is associated with mfr report number: 3005168196-2017-00060.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communication artery using penumbra smart coils (smart coils).During the procedure, the physician experienced resistance and was unable to advance two smart coils out of their introducer sheaths and into the non-penumbra microcatheter, therefore both smart coils were removed.The procedure was completed using the same non-penumbra microcatheter and a new smart coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the penumbra smart coil (smart coil) pusher assembly was bent in multiple locations.The embolization coil was intact with the pusher assembly and had offset coil windings.Conclusions: evaluation of the returned device revealed both embolization coils had offset coil windings.This type of damage typically occurs if the introducer sheath is not properly aligned within the hub when the smart coil is advanced.The damage observed on the embolization coils likely contributed to the resistance experienced by the physician when advancing the smart coils.Further evaluation revealed a white substance was present around both introducer sheaths.This substance was likely incidental and may have been transferred from the physician¿s gloves.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.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: 3005168196-2017-00060.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6244374
• Report Number: 3005168196-2017-00059
• Device Sequence Number: 16382588
• Product Code: HCG
• UDI-Device Identifier: 00814548015170
• UDI-Public: 00814548015170
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/15/2016

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: 02/24/2021
• Device Catalogue Number: 400SMTXSFT011H
• Device Lot Number: F68109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2017
• Supplement Report FDA Received Date: 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR