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

Catalog Number	400SMTHXSFT0410
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-00156.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, the physician successfully placed multiple smart coils into the target vessel using a non-penumbra microcatheter.The physician then advanced another smart coil through its introducer sheath, but it would not enter into the hub of the microcatheter.The smart coil was therefore removed and was not used in the procedure.A second smart coil was then advanced through its introducer sheath but the same issue occurred.The second smart coil was also removed and was not used in the procedure.The procedure was completed using additional smart coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact at the proximal end of the pusher assembly.Bends and kinks were present along the pusher assembly approximately 16.5 cm, 22.0 cm, 28.0 cm, 43.0 cm, 60.5 cm, 77.0 cm, 85.0 cm, 127.0 cm, 137.0 cm and 146.5 cm from the proximal end.The mid-joint was proximal to the introducer sheath friction lock.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).Offset coil winds were present on the proximal end of the embolization coil.Conclusions: evaluation of the first returned smart coil revealed proximal offset coil winds.If the introducer sheath is not seated properly within the hub of the parent catheter, resistance may be encountered while advancing the device.If the device is advanced against resistance, damage such as offset coil winds will likely occur.During functional testing, resistance was encountered at the hub of a demonstration microcatheter and the device could not advance any further.Further evaluation revealed kinks along the pusher assembly.These kinks are likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.Evaluation of the second smart coil revealed the pusher assembly mid-joint was proximal to the introducer sheath friction lock, pusher assembly kinks, and a fracture.If the introducer sheath is not seated properly within the hub of the parent catheter, resistance may be encountered while advancing the device.If the smart coil is forcefully advanced against this resistance, kinks and fractures may occur.Further evaluation revealed the embolization coil became detached from the ddt.Based on the reported complaint, some of the observed kinks, the fracture, and the detached embolization coil were likely incidental to the reported complaint.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.This report is associated with mfr report number: 1.3005168196-2019-00156.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the follow up #1 3005168196-2019-00156 mfr report and is being corrected on this follow-up # 2 3005168196-2019-00155 mfr report: 1.Section h.Box10.Narrative/corrected data.Results: the pet lock was intact at the proximal end of the pusher assembly.Bends and kinks were present along the pusher assembly approximately 16.5 cm, 22.0 cm, 28.0 cm, 43.0 cm, 60.5 cm, 77.0 cm, 85.0 cm, 127.0 cm, 137.0 cm and 146.5 cm from the proximal end.The mid-joint was proximal to the introducer sheath friction lock.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).Offset coil winds were present on the proximal end of the embolization coil.Conclusions: evaluation of the first returned smart coil revealed proximal offset coil winds.If the introducer sheath is not seated properly within the hub of the parent catheter, resistance may be encountered while advancing the device.If the device is advanced against resistance, damage such as offset coil winds will likely occur.During functional testing, resistance was encountered at the hub of a demonstration microcatheter and the device could not advance any further.Further evaluation revealed kinks along the pusher assembly.These kinks are likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.Evaluation of the second smart coil revealed the pusher assembly mid-joint was proximal to the introducer sheath friction lock, pusher assembly kinks, and a fracture.If the introducer sheath is not seated properly within the hub of the parent catheter, resistance may be encountered while advancing the device.If the smart coil is forcefully advanced against this resistance, kinks and fractures may occur.Further evaluation revealed the embolization coil became detached from the ddt.Cause was unable to be determined due to the extent of damage to the device before being received for evaluation.Based on the reported complaint, some of the observed kinks, the fracture, and the detached embolization coil were likely incidental to the reported complaint.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.This report is associated with mfr report number: 1.3005168196-2019-00156 h3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8279001
• Report Number: 3005168196-2019-00155
• Device Sequence Number: 1527987
• Product Code: HCG
• UDI-Device Identifier: 00814548015835
• UDI-Public: 00814548015835
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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): 12/27/2018
• 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 Catalogue Number: 400SMTHXSFT0410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 04/16/2019; 01/14/2005
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 05/14/2019; 07/30/2019
• 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