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

Catalog Number	400SMTSTD1260
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 5.5 though 10.0, 62.0, and 108.0 though 114.0 cm from the proximal end.The embolization was intact with its pusher assembly and had offset coil winds.Conclusions: evaluation of the first evaluated smart coil revealed that the pusher assembly was kinked.If the device is forcefully advanced against resistance, damage such as a kink may occur.Further evaluation of the returned smart coil revealed that the introducer sheath had coagulated blood inside.During the functional test, resistance was encountered while advancing the smart coil through a demonstration microcatheter and smart coil could not be advanced any further.The root cause of the initial resistance could not be determined.The coagulated blood likely contributed the resistance experienced during the functional test.Evaluation of the second evaluated smart coil revealed that the pusher assembly was kinked.If the device is forcefully advanced against resistance, damage such as a kink may occur.Further evaluation of the returned smart coil revealed embolization coil winds were offset.If the device is not re-sheath prior to returning the device to penumbra for evaluation, damage such as offset coil winds may occur.Evaluation of the non-penumbra microcatheter revealed that the device was ovalized distally.Both returned smart coils were unable to be functionally tested with the returned microcatheter.If the introducer sheath was misaligned within the hub prior to advancement it may have contributed to the inability to advance both smart coils into the non-penumbra microcatheter.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: 3005168196-2018-02129.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, the physician felt resistance and was unable to advance a smart coil through the hub of microcatheter and, therefore, the smart coil was removed.The physician then attempted to place another smart coil, however felt the same resistance.The physician attempted to force the coil forward and, consequently, the pusher assembly of the smart coil became kinked.Therefore, the smart coil was removed, and the procedure was 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 pusher assembly was kinked approximately 5.5 through 10.0, 62.0, and 108.0 through 114.0 cm from the proximal end.The embolization was intact with its pusher assembly and had offset coil winds.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8007496
• Report Number: 3005168196-2018-02130
• Device Sequence Number: 1658944
• Product Code: HCG
• UDI-Device Identifier: 00814548014449
• UDI-Public: 00814548014449
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2018
• 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: 04/19/2022
• Device Catalogue Number: 400SMTSTD1260
• Device Lot Number: F75776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005