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

Catalog Number	400SMTSFT0410
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
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 at approximately 83.0 cm, 84.0 cm and 144.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had an offset coil wind at its proximal end.The introducer sheath was not returned with the device for evaluation.The pusher assembly mid-joint outer diameter was unable to be measured due to the pusher assembly kinks.Conclusions: evaluation of the returned smart coil revealed a functional device.During functional testing, the embolization coil was able to be detached using a demonstration handle without an issue.The reported complaint could not be confirmed.The handle used in the procedure was not returned for evaluation.Further investigation revealed kinks on the pusher assembly and offset coil winds on the embolization coil.These damages were likely incidental to the complaint.Evaluation of the returned smart coil revealed offset coil wind on the proximal end of the embolization coil.If the smart coil is forcefully manipulated against resistance, damage such as offset coil winds may occur.During the functional testing, the smart coil was able to advance through a demonstration introducer sheath without an issue.The introducer sheath used in the complaint was not returned for evaluation; therefore, the root cause of the resistance could not be determined.Further investigation revealed kinks on the pusher assembly.These damages were likely incidental to the complaint.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: 3005168196-2019-01935.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left anterior cerebral artery (aca) using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician attempted to detach a smart coil using the handle and reported that it would not detach.Therefore, the smart coil was removed by manipulating the pusher wire.It was also reported that another smart coil would not advance through its introducer sheath.This smart coil was also removed.The procedure was completed using additional smart coils and the same handle.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: 9200083
• Report Number: 3005168196-2019-01934
• Device Sequence Number: 449541
• Product Code: HCG
• UDI-Device Identifier: 00814548015095
• UDI-Public: 00814548015095
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 09/17/2019
• 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: 10/16/2023
• Device Catalogue Number: 400SMTSFT0410
• Device Lot Number: F86514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• 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: 09/17/2019
• Initial Report FDA Received Date: 10/16/2019
• 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