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

Catalog Number	400SMTXSFT011H
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the embolization coil was intact with the penumbra smart coil (smart coil) pusher assembly and had offset coil winds near its proximal end.During functional analysis, resistance was experienced when advancing the smart coil through its introducer sheath.Furthermore, the smart coil could not be advanced into a demonstration microcatheter.Conclusions: evaluation of the returned device revealed that it had offset coil winds near the proximal end of the embolization coil.If the introducer sheath is not properly aligned inside the hub of the microcatheter prior to advancement, resistance may be encountered, and damage such as this may occur.The offset coil winds caused resistance when attempting to advance during functional analysis.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 using penumbra smart coils (smart coils).During the procedure, the physician deployed and detached initial smart coils into the patient using a non-penumbra microcatheter.While attempting to advance a new smart coil into the microcatheter, the physician was unable to advance the coil out of its introducer sheath and into the microcatheter.Therefore, the introducer sheath containing the smart coil was removed and the procedure was completed using a new smart coil and the same microcatheter.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: 7000273
• Report Number: 3005168196-2017-01960
• Device Sequence Number: 1353474
• Product Code: HCG
• UDI-Device Identifier: 00814548015170
• UDI-Public: 00814548015170
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 10/14/2017

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: 11/01/2020
• Device Catalogue Number: 400SMTXSFT011H
• Device Lot Number: F66300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2017
• Initial Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR