MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4002C3260
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2019
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.This report is associated with mfr report numbers: 3005168196-2019-01383, 3005168196-2019-01384.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400 (pc400) coils and a px slim delivery microcatheter(px slim).During the procedure, the physician experienced resistance while advancing a pc400 through a px slim, and when the physician pulled the delivery pusher the pc400 unintentionally detached.The physician therefore removed the px slim with the pc400 inside.The physician attempted to advance a new pc400 through the same px slim; however the physician experienced the same resistance and subsequently the delivery pusher was kinked.The physician removed the pc400 and the px slim.The procedure was completed using a new px slim and nine pc400 coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was slipped off and the pull tube was retracted from the proximal end of the pusher assembly.The pull wire was retracted, and the embolization coil was detached from the distal detachment tip (ddt).The embolization coil had offset coil winds.Conclusions: evaluation of the returned pc400 revealed offset coil winds on its embolization coil.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.The resistance was likely caused by the damaged px slim used in the procedure.Further investigation revealed that the pet lock was damaged and slipped off from its initial position, the pull tube was retracted from its initial position and the embolization coil was detached from the ddt.Based on the reported complaint these damages were likely incidental and could have happened during retracting the pc400 from the px slim.Evaluation of the returned pc400 confirmed that the pusher assembly was kinked near the proximal end of the introducer sheath and revealed that the embolization coil had offset coil winds.These damages typically occur if the device is forcefully advanced against resistance.The resistance was likely caused by the damaged px slim used in the procedure.Further investigation revealed additional kinks on the pusher assembly.These kinks were likely incidental to the complaint and could have occurred during packaging for return to penumbra.Evaluation of the returned px slim revealed ovalizations near the distal tip.If the device is forcefully gripped or pinched during the procedure, damage such as ovalizations may occur.These ovalizations likely contributed to the reported resistance experienced when advancing the pc400 through the px slim.During functional testing, resistance was encountered at the ovalization on the px slim while advancing a demonstration pc400 through the px slim and the pc400 could not be advanced through the ovalization on the catheter.Evaluation of the returned pc400 revealed the pusher assembly was kinked near the proximal end of the introducer sheath, the embolization coil had offset coil winds and the pull wire was advanced distal to ddt.These damages will typically occur if the device is forcefully advanced against resistance.This device was not mention in the complaint; therefore, the root cause of these damages could not be determined.Further investigation revealed additional kinks along the length of the pusher assembly and offset coil winds on the embolization coil.Based on the returned condition, these damages were likely incidental to the reported complaint.Evaluation of the returned px slim revealed a kink.The returned px slim was not mention in the complaint, and was successfully used to complete the procedure.The damage is therefore likely incidental to the reported complaint.Penumbra coils and catheters 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 numbers: 3005168196-2019-01383, 3005168196-2019-01384, 3005168196-2019-01582.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and are being corrected on this follow-up report:.1.Section b.Box 5.Describe event or problem 2.Section h.Box 10./11.Narrative/corrected data.This report is associated with mfr report numbers: 1.3005168196-2019-01383 2.3005168196-2019-01384 3.3005168196-2019-01582.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400 (pc400¿s) and a px slim delivery microcatheter (px slim).During the procedure, the physician experienced resistance while advancing a pc400 through a px slim, and when the physician pulled the pusher assembly the pc400 unintentionally detached.The physician therefore removed the px slim with the pc400 inside.The physician attempted to advance a new pc400 through the same px slim; however, the physician experienced the same resistance and subsequently the pusher assembly was kinked.The physician removed the pc400 and the px slim.The physician attempted to advance a new pc400 through a new px slim; however, the physician experienced the same resistance and subsequently the pusher assembly was also kinked.The physician removed the pc400.The procedure was completed using the px slim and nine pc400s.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8799385
• Report Number: 3005168196-2019-01382
• Device Sequence Number: 311469
• Product Code: HCG
• UDI-Device Identifier: 00814548012001
• UDI-Public: 00814548012001
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2019
• 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: 01/21/2025
• Device Catalogue Number: 4002C3260
• Device Lot Number: F73932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 07/17/2019; 09/26/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/16/2019; 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