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

Catalog Number	400SMTXSFT0104
Medical Device Problem Codes	Failure to Advance (2524); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra smart coil (smart coil) embolization coil was intact with the pusher assembly and had offset coil winds near its proximal end.During functional analysis, resistance was experienced while advancing the smart coils through their introducer sheaths.The smart coils could not be advanced into a demonstration microcatheter.Conclusions: evaluation of the returned devices revealed that both smart coil embolization coils had offset coil winds near their proximal ends.This type of damage typically occurs if the smart coil is forcefully advanced while the introducer sheath is not properly aligned inside the hub.This damage likely contributed to the resistance when advancing the smart coils 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.This report is associated with mfr report number: 3005168196-2017-01101.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the external carotid artery using penumbra smart coils (smart coils).During the procedure, the physician deployed and detached thirteen smart coils into the target vessel using a non-penumbra microcatheter.While the physician was attempting to advance a new smart coil through the microcatheter, the coil became stuck inside the hub of the microcatheter and was unable to advance further.The physician removed the smart coil and opened a new smart coil; however, the same issue occurred with this smart coil.Therefore, the smart coil was removed and the procedure was completed using two new smart coils 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: 6690155
• Report Number: 3005168196-2017-01100
• Device Sequence Number: 45674
• Product Code: HCG
• UDI-Device Identifier: 00814548015507
• UDI-Public: 00814548015507
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2017

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: 04/04/2021
• Device Catalogue Number: 400SMTXSFT0104
• Device Lot Number: F68781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR