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

Catalog Number	400SMTHXSFT0415
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
During preparation for a coil embolization procedure, the hospital staff advanced a penumbra smart coil (smart coil) into a bowl of saline on the back table.However, the hospital staff was unable to re-sheath the smart coil and therefore the smart coil was not used.The procedure was completed using a new smart coil.
Additional Manufacturer Narrative
Results: the pet lock was intact at the proximal end of the pusher assembly.The pusher assembly had bends approximately 8.0 cm and 12.0 cm from the proximal end.The mid-joint of the pusher assembly was proximal to the friction lock of the introducer sheath.The embolization coil was undamaged and intact with the distal detachment tip (ddt) of the pusher assembly.Conclusions: evaluation of the returned smart coil revealed the mid-joint of the pusher assembly was proximal to the friction lock of the introducer sheath.The inner diameter (id) of the friction lock is smaller than the rest of the introducer sheath allowing the introducer sheath to seat properly on the mid-joint of the pusher assembly.If the pusher assembly mid-joint is moved proximal to the introducer sheath friction lock, resistance may be encountered during subsequent attempts to advance the device.Further evaluation revealed bends along the pusher assembly.These bends are likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the follow up #1 3005168196-2019-00194 mfr report and is being corrected on this follow-up #2 3005168196-2019-00194 mfr report: 1.Section h.Box6.Results code 3, 2.Section h.Box6.Conclusions code 1, 3.Section h.Box10.Narrative/corrected data.Results: the pet lock was intact at the proximal end of the pusher assembly.The pusher assembly had bends approximately 8.0 cm and 12.0 cm from the proximal end.The mid-joint of the pusher assembly was proximal to the friction lock of the introducer sheath.The embolization coil was undamaged and intact with the distal detachment tip (ddt) of the pusher assembly.During functional testing, resistance was experienced unseating the pusher assembly mid-joint from the friction lock.Subsequently, the smart coil was able to advance out of its introducer sheath and a demonstration microcatheter without issue.Conclusions: evaluation of the returned smart coil revealed the embolization coil was re-sheathed upon return.The reported complaint was unable to be confirmed.Functional testing revealed the device performed as intended.Further evaluation revealed bends along the pusher assembly.These bends did not affect device functionality during testing and are likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8315116
• Report Number: 3005168196-2019-00194
• Device Sequence Number: 16549016
• Product Code: HCG
• UDI-Device Identifier: 00814548015842
• UDI-Public: 00814548015842
• 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,Followup,Followup
• Report Date (Section B): 01/08/2019
• 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: 04/15/2023
• Device Catalogue Number: 400SMTHXSFT0415
• Device Lot Number: F82849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 04/16/2019; 07/11/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 05/07/2019; 08/09/2019
• 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