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

Catalog Number	4002C1245
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-01392.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using a penumbra coil 400 (pc400) and a lantern delivery microcatheter (lantern).During the procedure, while advancing a pc400 through the lantern, the physician experienced resistance at the middle of the lantern; therefore, the physician attempted to remove the pc400.However, while retracting the pc400, it became stuck in the lantern; therefore, the physician removed the lantern with the pc400 together.While attempting to remove the pc400 from the lantern outside of the patient¿s body, the pc400 broke.The procedure was successfully completed by using another catheter and coils.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 penumbra coil 400 (pc400) pusher assembly.The pull wire was within pusher assembly distal detachment tip (ddt).The embolization coil was detached from the pusher assembly and had offset coil winds.The introducer sheath was damaged at approximately 3.0 cm from its proximal end.Coagulated blood was present on the embolization coil.Conclusions: evaluation of the returned lantern revealed a functional and an undamaged device.During functional testing, a demonstration pc400 was able to advance through the lantern without an issue.The reported complaint was unable to be confirmed.Evaluation of the returned pc400 revealed that the embolization coil had offset coil winds along its length and was detached from the pusher assembly.If the pc400 is forcefully manipulated against resistance, damage such as this may occur.During functional testing, a demonstration pc400 was able to advance through the returned lantern.The cause of the resistance was unable to be determined.Further investigation revealed the introducer sheath was damaged.This was not mentioned in the reported complaint; therefore, this damage was likely incidental to the complaint 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: 3005168196-2019-01392.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8807094
• Report Number: 3005168196-2019-01391
• Device Sequence Number: 319746
• 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): 06/19/2019
• 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: 11/14/2025
• Device Catalogue Number: 4002C1245
• Device Lot Number: F80572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005