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

Catalog Number	4006C0306
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2018
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 numbers: 3005168196-2018-00400.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left vertebral artery using penumbra coils 400 (pc400's).During the procedure, the physician deployed and detached a pod packing coil (podj) in the target vessel using a px slim delivery microcatheter (px slim).While attempting to advance a pc400 into the px slim, the physician noticed that the pc400 introducer sheath was thin and the coil would not advance out of the sheath.Therefore, the physician removed the pc400 introducer sheath and attempted to load the pc400 into the previously used podj introducer sheath; however, the pc400 became detached in the process.Subsequently, the pc400 was set aside and the physician opened a new pc400.While attempting to advance the new pc400 into the px slim, the pc400 would not advance out of its introducer sheath; therefore, it was removed.The procedure was completed using additional pc400's and the same px slim.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 second pc400 evaluated.The pusher assembly was kinked approximately 5.0 and 129.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.The introducer sheath was ovalized and stretched approximately 3.5 cm from the proximal end and the pet friction lock was advanced approximately 9.5 cm from the proximal end.Resistance was encountered while attempting to advance the second evaluated pc400 out of its introducer sheath and the pc400 could not be advanced any further.Conclusions: evaluation of the first pc400 revealed that pusher assembly and embolization coil sr wire were fractured and the pusher assembly was twisted together.If the device is retracted through the introducer sheath friction lock in attempt to use a different sheath, damage such as an sr wire fracture may occur.This is due to the proximal portion having a larger outer diameter (od) than the inner diameter (id) of the introducer sheath friction lock.Further evaluation of the returned pc400 revealed that the pusher assembly was twisted together.This damage was likely incidental and may have occurred while packaging of the device for return to penumbra.The returned condition of the first evaluated pc400 limited the penumbra investigators ability to evaluate the pusher assembly.Evaluation of the second pc400 revealed that the introducer sheath was ovalized.If the introducer sheath is forcefully gripped or pinched during advancement, damage such as ovalization may occur.Further evaluation of the returned pc400 revealed that the pet heat shrink was distal to its manufactured location.This type of damage likely occurred due to forceful manipulation while trying to advance the coil out of its sheath.The px slim identified in the complaint was not returned to penumbra 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.This report is associated with mfr report numbers: 3005168196-2018-00400.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG. KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7292365
• Report Number: 3005168196-2018-00401
• Device Sequence Number: 19089952
• Product Code: HCG
• UDI-Device Identifier: 00814548011721
• UDI-Public: 00814548011721
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2018

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: 03/11/2025
• Device Catalogue Number: 4006C0306
• Device Lot Number: F74948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR