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

Model Number	400SMTSTD1245
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2018
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 138.0 cm from the proximal end.The embolization coil was intact with its pusher assembly and the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The inner diameter of the introducer sheath and the outer diameter of the pusher assembly mid-joint were measured to be within specification.Resistance was encountered while attempting to advance the smart coil pusher assembly through its introducer sheath and the pusher assembly became kinked by the penumbra investigator.After the pusher assembly was kinked the pusher assembly was unable to advanced out of its introducer sheath.Conclusions: evaluation of the first evaluated smart coil revealed a functional, undamaged device.During the functional test, the smart coil was advanced through a demonstration microcatheter and out of the distal tip without an issue.The device was free of damage and the reported complaint could not be confirmed.Evaluation of the second evaluated smart coil revealed that the embolization coil winds were offset.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, damage such as this may occur.In addition, the smart coil was returned without its introducer sheath.Further evaluation of the returned smart coil revealed that the pusher assembly was kinked in multiple locations.These kinks were likely incidental and may have occurred due to packaging of the device for return to penumbra.During the functional test, resistance was encountered as the kinks in the pusher assembly were being retracted through the demonstration introducer sheath and the pusher assembly could not be retracted any further.The offset coil winds may have contributed to the reported advancement issue during the procedure.Evaluation of the third evaluated smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If the mid-joint is retracted proximal to the friction lock, resistance may be encountered upon attempting to advance the coil out of its sheath.During the functional test resistance was encountered while attempting to advance the smart coil pusher assembly through its introducer sheath and the pusher assembly became kinked by the penumbra investigator.Evaluation of the fourth evaluated smart coil revealed that the pusher assembly was advance distal to the introducer sheath friction lock.During the functional test, the smart coil was advanced through a demonstration microcatheter and out of the distal tip without an issue.Since the device was returned with the mid-joint advanced distal to the introducer sheath friction lock, the root cause of the smart coil¿s inability to be advanced within its introducer sheath could not be determined.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 numbers: 3005168196-2018-01975; 3005168196-2018-01977.
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 two smart coils within their introducer sheaths and, therefore, the smart coils were removed.The physician then successfully placed multiple non-penumbra coils using the same non-penumbra microcatheter.The physician then attempted to place another smart coil, however, the physician felt resistance and was unable to advance the coil fully out of the tip of the microcatheter.The smart coil was therefore removed, and the physician successfully placed a different coil.The physician then attempted to place another smart coil, however, the physician again felt resistance and was unable to advance the smart coil fully out of the tip of the microcatheter.The smart coil was therefore removed, and the procedure was completed using new 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 on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 138.0 cm from the proximal end.The embolization coil was intact with its pusher assembly and the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The inner diameter of the introducer sheath and the outer diameter of the pusher assembly mid-joint were measured to be within specification.Resistance was encountered while attempting to advance the smart coil pusher assembly through its introducer sheath and the pusher assembly became kinked by the penumbra investigator.After the pusher assembly was kinked the pusher assembly was unable to advanced out of its introducer sheath.Conclusions: evaluation of the first evaluated smart coil revealed a functional, undamaged device.During the functional test, the smart coil was advanced through a demonstration microcatheter and out of the distal tip without an issue.The device was free of damage and the reported complaint could not be confirmed.Evaluation of the second evaluated smart coil revealed that the embolization coil winds were offset.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, damage such as this may occur.In addition, the smart coil was returned without its introducer sheath.Further evaluation of the returned smart coil revealed that the pusher assembly was kinked in multiple locations.These kinks were likely incidental and may have occurred due to packaging of the device for return to penumbra.During the functional test, resistance was encountered as the kinks in the pusher assembly were being retracted through the demonstration introducer sheath and the pusher assembly could not be retracted any further.The offset coil winds may have contributed to the reported advancement issue during the procedure.Evaluation of the third evaluated smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If the mid-joint is retracted proximal to the friction lock, resistance may be encountered upon attempting to advance the coil out of its sheath.During the functional test resistance was encountered while attempting to advance the smart coil pusher assembly through its introducer sheath and the pusher assembly became kinked by the penumbra investigator.Evaluation of the fourth evaluated smart coil revealed that the pusher assembly was advanced distal to the introducer sheath friction lock.During the functional test, the smart coil was advanced through a demonstration microcatheter and out of the distal tip without an issue.Since the device was returned with the mid-joint advanced distal to the introducer sheath friction lock, the root cause of the smart coil¿s inability to be advanced within its introducer sheath could not be determined.Further evaluation of the returned smart coil revealed a kink in the pusher assembly.This kink was likely incidental to the reported complaint and may have occur during packing for return.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 numbers: 3005168196-2018-01975 and 3005168196-2018-01977.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7950100
• Report Number: 3005168196-2018-01976
• Device Sequence Number: 19168362
• Product Code: HCG
• UDI-Device Identifier: 00814548014432
• UDI-Public: 00814548014432
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 09/10/2018
• 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: 06/07/2022
• Device Model Number: 400SMTSTD1245
• Device Catalogue Number: 400SMTSTD1245
• Device Lot Number: F77546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005