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

Catalog Number	4002C1857
Medical Device Problem Codes	Detachment Of Device Component (1104); Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2017-00765, 3005168196-2017-00766, 3005168196-2017-00767, 3005168196-2017-00768, 3005168196-2017-00769, 3005168196-2017-00770.Device was discarded by the hospital.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coils 400 (pc400s).It was noted that the patient had a tortuous anatomy.During the procedure, the physician advanced a pc400 (f65128) into the aneurysm using a px slim delivery microcatheter (px slim).The physician then attempted to detach the pc400 using a penumbra coil 400 detachment handle (handle); however, the pc400 failed to detach.It was noted that the black alignment zone (pet lock) on the pusher assembly only showed a small gap of 0.5 cm.The physician then attempted to reposition the px slim; however, it did not improve the situation; therefore, the physician attempted to retract the pc400.Upon retraction, the pc400 unintentionally detached within the px slim and the physician used the pusher assembly to push the detached pc400 into the aneurysm.Next, the physician advanced the second pc400 (f67056) into the aneurysm; however, the physician encountered the same difficulty while attempting to detach the pc400 using the same handle.Repositioning the px slim did not help.The pc400 was then manually detached in the aneurysm.It was reported that when manually detaching this pc400, resistance was encountered and the pull wire stayed in place; therefore, additional force was required to successfully detach this pc400.Next, the physician deployed and detached the third pc400 in the target vessel using the same px slim and handle with no issue.The physician then advanced the fourth pc400 (f71453) into the aneurysm; however, the same difficulty was encountered as with the second pc400 when attempting to detach this pc400 using the handle; therefore, the pc400 was manually detached.Thereafter, the physician deployed and detached the fifth and sixth pc400¿s in the target vessel without any issue.However, after advancing and deploying the seventh pc400 (f66227) and eighth pc400 (a64706) into the aneurysm, the physician experienced difficulty detaching them using the handle; therefore, they were both detached manually and the procedure was completed at that point.The physician indicated that another handle was used in between without improving the situation.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: 6578409
• Report Number: 3005168196-2017-00764
• Device Sequence Number: 11025297
• Product Code: HCG
• UDI-Device Identifier: 00814548010748
• UDI-Public: 00814548010748
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2017

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: Physician
• Device Expiration Date: 07/28/2023
• Device Catalogue Number: 4002C1857
• Device Lot Number: F65128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2017
• Initial Report FDA Received Date: 05/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR