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

Catalog Number	400SMTXSFT0103
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-00308.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a dural arteriovenous fistula (davf) using penumbra smart coils (smart coils).During the procedure, the physician successfully placed three coils using a non-penumbra microcatheter.The physician then encountered resistance and was unable to advance two smart coils within their introducer sheaths and, therefore, the smart coils were removed.The procedure was then completed using new coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with its pusher assembly and had offset coil winds.Conclusions: evaluation of the first and second smart coils revealed both embolization coils had offset coil winds.If the introducer sheath is not properly aligned within the hub of the parent device prior to advancement, resistance may be encountered.If a smart coil is forcefully advanced against resistance, damage such as offset coil winds may occur.During functional testing, the first embolization coil bunched up inside the introducer sheath and could not be advanced further.The first smart coil resistance occurred while advancing the coil within its introducer sheath.The second smart coil took shape inside the hub of the demonstration catheter and could not be advanced any further.The offset coil winds likely caused the devices¿ inability to advance during functional testing.The non-penumbra microcatheter identified in the complaint was not returned to penumbra for evaluation.Penumbra coils are visually 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: 1.3005168196-2019-00308.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8358341
• Report Number: 3005168196-2019-00309
• Device Sequence Number: 206619
• Product Code: HCG
• UDI-Device Identifier: 00814548015194
• UDI-Public: 00814548015194
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 11/07/2021
• Device Catalogue Number: 400SMTXSFT0103
• Device Lot Number: F72693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005