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

Catalog Number	400SMTSTD0830
Medical Device Problem Codes	Detachment Of Device Component (1104); Physical Resistance (2578); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2018
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 44.0, 46.0 and 164.0 cm from the proximal end.The embolization coil was detached from its pusher assembly and had offset coil winds in multiple locations.Conclusions: evaluation of the returned device revealed that the smart coils embolization coil had offset coil winds in multiple locations.This type of damage likely occurred due to manipulation against resistance.Further evaluation of the returned device revealed that the embolization coil was detached from its pusher assembly.If the smart coil is forcefully retracted while the embolization coil is pinned, the polymer section of the pusher assembly may elongate, causing the ddt to advance beyond the reach of the pull wire, and subsequently causing the embolization coil to unintentionally detach.The non-penumbra microcatheter referred to 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 in the right traverse sinus to treat a dural arteriovenous fistula (d-avf) using penumbra smart coils (smart coils).It was noted that the patient's anatomy was slightly tortuous and there was slight stenosis.During the procedure, the physician placed seven non-penumbra coils and one smart coil in the target vessel using a non-penumbra microcatheter.While attempting to place a new smart coil in the target vessel, the physician noticed that the smart coil did not pack well and decided to remove it; however, while attempting to retract the smart coil, resistance was encountered and subsequently, the smart coil unintentionally detached.Therefore, the physician removed the microcatheter containing the detached coil and removed the coil.The microcatheter was then reinserted into the patient¿s body and the procedure was completed using the same microcatheter and other coils.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: 7329196
• Report Number: 3005168196-2018-00497
• Device Sequence Number: 1605118
• Product Code: HCG
• UDI-Device Identifier: 00814548014524
• UDI-Public: 00814548014524
• 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): 02/07/2018
• 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: Physician
• Device Expiration Date: 07/13/2022
• Device Catalogue Number: 400SMTSTD0830
• Device Lot Number: F78150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Date Report Sent to FDA: 01/01/2005