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

Catalog Number	4002C1857
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2018
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 141.0 cm from the proximal end.The embolization coil was intact with its pusher assembly and had offset coil winds.The pc400 was advanced through a demonstration microcatheter and out of the distal tip without an issue.However, while retracting the pc400 into its introducer sheath during re-sheathing, resistance was encountered as the offset coil winds began to compress inside the introducer sheath.Conclusions: evaluation of the returned pc400 revealed that the embolization coil winds were offset.If the coil is returned un-sheathed, damage such as offset coil winds may occur.Further evaluation of the returned pc400 revealed that the device was able to re-sheathed and advanced through a demonstration microcatheter without an issue.Therefore, the root cause of the reported resistance could not be determined.Upon re-sheathing the pc400 after the functional test, resistance was encountered as the offset coil winds began to bunch up inside the introducer sheath and the pc400 could not be advanced any further.Evaluation of the returned handle revealed that a piece of pet heat shrink tubing was stuck inside the nosecone.If the handle is actuated during an attempt to detach a coil, the pet heat shrink tubing may become stuck inside the nosecone of the handle.During the functional test, the pet lock heat shrink tubing was removed from the nosecone and the handle was functionally tested within specification.The pet heat shrink tubing from the pusher assembly may have contributed to the handle inability of detaching the coil during the procedure.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: 3005168196-2018-02133; 3005168196-2018-02134.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400s) and a penumbra coil detachment handle (handle).During the procedure, the physician successfully placed one pc400 using a non-penumbra microcatheter.The physician then felt resistance while advancing another pc400 within the microcatheter and, therefore, the pc400 was removed.The physician then successfully placed two p400s.The physician then attempted to place another pc400, however was unable to detach the embolization coil using the handle.The physician therefore used a new handle to successfully detach the coil.The procedure was then completed using five additional 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: 8007645
• Report Number: 3005168196-2018-02132
• Device Sequence Number: 1151020
• Product Code: HCG
• UDI-Device Identifier: 00814548010748
• UDI-Public: 00814548010748
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2018
• 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 Expiration Date: 10/28/2023
• Device Catalogue Number: 4002C1857
• Device Lot Number: F66239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2018
• 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: 09/27/2018
• Initial Report FDA Received Date: 10/25/2018
• 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