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

Catalog Number	4002C1040
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pusher assembly was kinked approximately 93.0 and 141.0 cm from the proximal end.The pusher assembly midjoint was retracted proximal to the introducer sheath friction lock.The embolization coil was intact with the pusher assembly.Dried blood was observed throughout the introducer sheath and embolization coil.Conclusions: evaluation of the returned device revealed the penumbra coil 400 (pc400) could not be advanced through its introducer sheath due to the location of the pusher assembly midjoint and the dried blood inside the introducer sheath.The introducer sheath friction lock inner diameter (id) is smaller than the rest of the introducer sheath, which allows the introducer sheath to properly seat on the pusher assembly midjoint.If the pusher assembly midjoint is forcefully withdrawn beyond the introducer sheath friction lock, it is likely that resistance will be experienced by the physician upon attempting to advance the ruby coil.The pusher assembly mid-joint being retracted proximal to the introducer sheath friction lock may have contributed to the inability to advance the ruby coil during the procedure.When the pc400 was flushed out of the bloody introducer sheath and re-sheathed by a penumbra investigator, it was advanced into and through a demonstration microcatheter without issue.Further evaluation revealed the pusher assembly was kinked.This damage was likely incidental and may have occurred during packaging for return to penumbra.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal iliac artery (iia) using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed four pc400s using a non-penumbra microcatheter.The physician then felt resistance and was unable to advance another pc400 through the hub of the microcatheter, despite multiple attempts.The physician therefore removed the pc400 and completed the procedure using new 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: 7084042
• Report Number: 3005168196-2017-02148
• Device Sequence Number: 1297951
• Product Code: HCG
• UDI-Device Identifier: 00814548010601
• UDI-Public: 00814548010601
• Combination Product (Y/N): N
• 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): 11/07/2017

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: 10/19/2024
• Device Catalogue Number: 4002C1040
• Device Lot Number: F72415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR