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

Catalog Number	4006C0408
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed three pod coils in the target vessel using a lantern delivery microcatheter (lantern).While attempting to advance a pc400 over the hub of the lantern, the physician experienced resistance; therefore, the pc400 was removed, and the lantern was flushed.The physician then encountered resistance again while attempting to re-advance the pc400 over the hub of the lantern; therefore, the pc400 was removed.The procedure was completed using two other pc400s and the same lantern.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed three pod coils in the target vessel using a lantern delivery microcatheter (lantern).While attempting to advance a pc400 through the hub of the lantern, the physician experienced resistance; therefore, the pc400 was removed, and the lantern was flushed.The physician then encountered resistance again while attempting to re-advance the pc400 through the hub of the lantern; therefore, the pc400 was removed.The procedure was completed using two other pc400s and the same lantern.There was no report of an adverse effect to the patient.
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 #01 mfr report: 3005168196-2019-01683.Results: the embolization coil was detached from its pusher assembly and was within the introducer sheath.The proximal constraint sphere was not present on the proximal end of the embolization coil.Offset coil winds were present throughout the length of the embolization coil.The introducer sheath was ovalized approximately 62.0 cm from the proximal end, 3.0 cm from the distal end.Coagulated blood was within the introducer sheath.Conclusions: evaluation of the returned pc400 revealed the introducer sheath was ovalized on the distal tip and the embolization coil had offset coil winds.If the pc400 was forcefully advanced against resistance, offset coil winds may result.This introducer sheath ovalization may have contributed to this resistance.Further evaluation revealed the embolization coil was detached from its pusher assembly and the proximal constraint sphere was not present on the proximal end of the embolization coil.This likely indicates that the stretch resistant (sr) wire was fractured.This type of damage typically occurs if the device is forcefully retracted against resistance.These damages were not mentioned in the reported complaint and were likely incidental to the reported complaint.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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8962989
• Report Number: 3005168196-2019-01683
• Device Sequence Number: 16784700
• Product Code: HCG
• UDI-Device Identifier: 00814548011905
• UDI-Public: 00814548011905
• 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
• Report Date (Section B): 08/06/2019
• 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: 05/27/2026
• Device Catalogue Number: 4006C0408
• Device Lot Number: F83685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005