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

Catalog Number	4004C0513
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	01/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the embolization coil was detached from the pusher assembly, had offset coil winds and gaps, and the stretch resistant wire (sr wire) was fractured on the proximal end.Conclusions: evaluation of the returned device revealed the embolization coil was detached from the pusher assembly, had offset coil winds and gaps, and the stretch resistant wire (sr wire) was fractured on the proximal end.Fracture of the sr wire typically occurs due to forceful retraction of the pc400 against resistance, and will cause the embolization coil to detach.Since the pc400 was reportedly removed from the procedure with no mention of detachment, this damage was likely incidental to the reported issue.Offset coil winds and gaps typically occur due to forceful advancement of the pc400 against resistance.Since none of the other pc400 components and devices from the procedure were returned for evaluation, the root cause of the reported resistance could not be determined.The pc400 pusher assembly and introducer sheath and the non-penumbra microcatheter were not returned for evaluation.Penumbra coils 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 coils 400 (pc400¿s).During the procedure, the physician placed three pc400¿s and four non-penumbra coils in the target vessel using a non-penumbra microcatheter.While attempting to advance a new pc400 through the microcatheter, the physician experienced resistance half way through the microcatheter and the pc400 would not advance further.Therefore, the physician removed the microcatheter containing the pc400.The procedure was completed using a new microcatheter and five additional pc400¿s.There was no report of an adverse effect.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7306729
• Report Number: 3005168196-2018-00440
• Device Sequence Number: 19203364
• Product Code: HCG
• UDI-Device Identifier: 00814548010861
• UDI-Public: 00814548010861
• 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): 02/01/2018

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: 04/08/2025
• Device Catalogue Number: 4004C0513
• Device Lot Number: F75487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR