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

Catalog Number	4004C0720
Medical Device Problem Codes	Detachment Of Device Component (1104); Retraction Problem (1536); Unraveled Material (1664); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the stretch resistance wire (sr wire) was fractured; the penumbra coil 400 coil (pc400 coil) was inside the non-penumbra device.The undamaged section of the pc400 coil was measured and found to be within specification.Conclusions: evaluation of the returned device revealed that the sr wire was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully retracted against resistance, damage such as this may occur.The pusher assembly to the pc400 coil was not returned for evaluation.These devices are 100% functionally tested during in-process inspection.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 celiac artery using penumbra coil 400 coils (pc400 coils).During the procedure the physician advanced another manufacturer's catheter and the px slim delivery microcatheter (px slim) into the celiac artery and then advanced a pc400 coil through the px slim and into the target vessel; however, the pc400 coil did not coil properly because its size was larger than the aneurysm.After several unsuccessful attempts to properly settle the pc400 coil in the aneurysm, the physician decided to withdraw the coil.While the pc400 coil was being retracted back into the px slim, it became stuck and was unable to be retracted after approximately 5-6cm.The physician forcefully pulled on the pc400 coil pusher assembly and the pc400 coil unintentionally detached and started to unravel inside the px slim.The physician then removed the other manufacturer's catheter containing the px slim and the pc400 coil from the patient.The procedure was completed using a smaller-sized pc400 coil, the same px slim and the same catheter from the other manufacturer.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5427281
• Report Number: 3005168196-2016-00152
• Device Sequence Number: 13607879
• Product Code: HCG
• UDI-Device Identifier: 00814548010915
• UDI-Public: 00814548010915
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2016

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: 07/26/2023
• Device Catalogue Number: 4004C0720
• Device Lot Number: F65058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2016
• Initial Report FDA Received Date: 02/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1