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

Catalog Number	400SMTXSFT011H
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was separated on the proximal end of the pusher assembly and the pull wire was retracted from the distal detachment tip (ddt).The embolization coil was detached from the pusher assembly and embolization coil had kinks and offset coil winds.The pusher assembly was bent approximately 74.0 cm and 95.0 cm from the proximal end.The introducer sheath was not returned for evaluation.Embolization coil was detached from its pusher assembly; therefore, functional testing was not performed.Conclusions: evaluation of the returned device revealed a device with a detached embolization coil and separated proximal pet lock.The reported complaint mentioned the smart coil was unable to advance through its introducer sheath.The introducer sheath was not returned for evaluation; therefore, the reported complaint was unable to be confirmed.Further evaluation revealed an embolization coil with kinks and offset coil winds.Based on the reported complaint and return condition, the kinks and offset coil winds are likely incidental to the complaint and may have occurred during packaging for return to penumbra.Further evaluation revealed a detached embolization coil.The pet lock was separated and the pull wire was retracted from the distal detachment tip (ddt).If this occurs, the embolization coil will detach as intended.Based on the reported complaint, the detachment of the embolization coil is likely incidental to the reported complaint.The root cause of the detachment was unable to be determined.Further evaluation revealed kinks on the pusher assembly.Based on the return condition and the reported complaint, the kinks are likely incidental to the complaint and may have occurred during packaging for return to penumbra.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
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, the physician was unable to advance a smart coil through its introducer sheath and into the non-penumbra microcatheter.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8082068
• Report Number: 3005168196-2018-02268
• Device Sequence Number: 19275067
• Product Code: HCG
• UDI-Device Identifier: 00814548015170
• UDI-Public: 00814548015170
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2018
• 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: 08/22/2022
• Device Catalogue Number: 400SMTXSFT011H
• Device Lot Number: F78796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 11/17/2018
• 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