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

Catalog Number	4002C3260
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Result: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly; the pusher assembly was kinked approximately 1.5, 5.0, 78.0 and 87.0 cm from the proximal end; the stretch resistant wire (sr wire) was fractured and the embolization coil was unraveled.Conclusion: evaluation of the returned devices revealed that the pc400 sr wire was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully withdrawn against resistance, damage such as this may occur.Further evaluation revealed that the pusher assembly was kinked.This type of damage typically occurs due to improper handling during use.If the device is forcefully advanced against resistance, damage such as this may occur.Evaluation of the returned px slim delivery microcatheter (px slim) revealed that the catheter shaft was fractured.This type of damage likely occurs due to improper handling during use.If the device is forcefully manipulated, damage such as this may occur.Further evaluation revealed that the non-penumbra device was ovalized with the fractured distal portion of the px slim stuck inside.The ovalization in the non-penumbra device likely contributed to the resistance that was experienced during advancement and retraction of the pc400.Pc400s are 100% functionally tested during in-process inspection.Px slims are 100% visually inspected during in-process inspection.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: 3005168196-2016-00891.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coils 400 (pc400) with a px slim delivery microcatheter (px slim).During the procedure, after deploying two loops of a pc400 in the target vessel, the physician noticed the pc400 was unable to advance any further.While attempting to retract the pc400 back into the px slim, the physician experienced resistance; therefore, the pc400 and px slim were removed from the patient.The px slim was reinserted in the patient and after flushing control contrast, the physician noticed the px slim was broken between the hub and the strain relief.The px slim was removed and the procedure was completed using 10 additional pc400 coils with another manufacturer's microcatheter.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: 5746762
• Report Number: 3005168196-2016-00890
• Device Sequence Number: 13515694
• Product Code: HCG
• UDI-Device Identifier: 00814548012001
• UDI-Public: 00814548012001
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2016

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: 10/31/2022
• Device Catalogue Number: 4002C3260
• Device Lot Number: F60920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2016
• Initial Report FDA Received Date: 06/23/2016
• 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