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

Catalog Number	400SMTSFT0408
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/04/2018
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 137.5 cm from the proximal end.The embolization coil was intact with its pusher assembly.The smart coil was able to be removed from its packaging hoop with some resistance due to the pusher assembly kink.The smart coil was able to be advanced from its initial position with resistance, but not past the kink in the pusher assembly.Conclusions: evaluation of the return smart coil revealed that the device was kinked.The smart coil was able to be removed from its packaging hoop with some resistance due to the pusher assembly kink.The root cause of the difficulty removing the smart coil from its packaging hoop during preparation could not be determined.If the pusher assembly is mishandled or forcefully advanced against resistance, damage such as a kink may occur.Further evaluation of the returned smart coil revealed resistance during the functional test while advancing the pusher assembly from its initial position.The smart coil was advanced from its initial position with resistance, but not past the kink in the pusher assembly.Therefore, the embolization coil could not be completely advanced out of its introducer sheath.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.
Event or Problem Description
During preparation for a coil embolization procedure, the physician was unable to remove a penumbra smart coil (smart coil) out of its dispenser hoop; therefore, it was not used in the procedure.The procedure was completed using another smart coil.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7735764
• Report Number: 3005168196-2018-01496
• Device Sequence Number: 19062579
• Product Code: HCG
• UDI-Device Identifier: 00814548015088
• UDI-Public: 00814548015088
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2018
• 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: 06/20/2022
• Device Catalogue Number: 400SMTSFT0408
• Device Lot Number: F77825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 07/04/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 07/31/2018
• 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