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

Catalog Number	4002C1245
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	06/21/2019
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.This report is associated with mfr report number: 3005168196-2019-01492.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using penumbra coil 400s (pc400) and a lantern delivery microcatheter (lantern).During the procedure, while attempting to advance the pc400, the physician experienced resistance approximately 15 centimeters past the hub of the lantern.It was reported that the physician flushed the microcatheter to break resistance, however, was unsuccessful.Therefore, the lantern and pc400 were removed.The procedure was completed using three new pc400s and a new lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked at approximately 70.0 cm, 71.0 cm and 142.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds.Conclusions: evaluation of the returned lantern revealed an ovalization near its distal tip.If the lantern is forcefully gripped or pinched during preparation, damage such as an ovalization may occur.A demonstration pc400 was attempted to be advanced through the returned lantern during functional testing and the embolization coil could not advance past the ovalization on the lantern.The ovalization on the lantern likely contributed to the reported resistance experienced during the procedure and during the functional test.Evaluation of the returned pc400 revealed offset coil winds along the length of the embolization coil and kinks on its pusher assembly.If the pc400 is forcefully advanced against resistance, damage such as these may occur.The introducer sheath was not returned for evaluation.During functional testing, the pc400 was re-sheathed using a demonstration introducer sheath.While attempting to advance the pc400 within the introducer sheath, resistance was experienced due to the offset coil winds and the coil could not be advanced at all.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.This report is associated with mfr report number: 3005168196-2019-01492 h3 other text : placeholder.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8853307
• Report Number: 3005168196-2019-01493
• Device Sequence Number: 10827954
• Product Code: HCG
• UDI-Device Identifier: 00814548010649
• UDI-Public: 00814548010649
• 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): 07/04/2019
• 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: 01/06/2026
• Device Catalogue Number: 4002C1245
• Device Lot Number: F81330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 08/28/2019
• 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
• Date Report Sent to FDA: 01/01/2005