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

Catalog Number	400SMTSTD0725
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra smart coil (smart coil)introducer sheath was re-loaded backwards on the pusher assembly.The embolization coil was intact with the pusher assembly.The embolization coil had offset coil windings and was knotted.Conclusions: evaluation of the returned devices revealed the embolization coil had offset coil windings.This type of damage typically occurs if the introducer sheath is not properly seated in the hub of the microcatheter while the smart coil is advanced.If the introducer sheath is not properly seated in the microcatheter hub, the smart coil may take shape inside the hub and subsequently become damaged or knotted.The offset coil windings likely contributed to the resistance experienced when advancing the smart coil during the procedure.Further evaluation revealed the introducer sheath was re-loaded backwards onto the pusher assembly.If the introducer sheath is improperly re-loaded onto the pusher assembly, it will likely cause resistance when attempting to advance the smart coil.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, the physician was unable to advance a smart coil out of its introducer sheath and into a non-penumbra microcatheter; therefore, the smart coil was removed.The procedure was completed using the same microcatheter and a new smart coil.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6354943
• Report Number: 3005168196-2017-00246
• Device Sequence Number: 1041822
• Product Code: HCG
• UDI-Device Identifier: 00814548014555
• UDI-Public: 00814548014555
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 01/26/2017

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: 08/24/2020
• Device Catalogue Number: 400SMTSTD0725
• Device Lot Number: F65477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2017
• Initial Report FDA Received Date: 02/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR