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

Catalog Number	4004C0615
Medical Device Problem Codes	Retraction Problem (1536); Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that the following device code also applies to this complaint: (b)(4).The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a pulmonary arteriovenous malformation (avf) using penumbra coil 400¿s (pc400's).During the procedure, the physician placed a non-penumbra angiographic balloon catheter into the pulmonary artery and then advanced a non-penumbra catheter and guide wire toward the feeder.The angiographic balloon catheter was then inflated and a pc400 was deployed and detached into the target vessel.While advancing a new pc400 through the catheter, the physician felt gradual resistance and subsequently, the pc400 became stuck inside the catheter.The physician then attempted to re-sheath the pc400 by pulling it back; however, resistance was encountered and the pc400 would not retract back into its introducer sheath.Therefore, the physician removed the catheter with the pc400 still inside.After the devices were removed from the patient, the physician removed the pc400 from the catheter; however, the pc400 became unraveled.The physician then inspected the catheter by advancing a guide wire through it and found no issues.Thereafter, the catheter was reinserted into the patient and a new pc400 was deployed and detached into the target vessel.The procedure was then successfully completed using three new pc400's and the same catheter.It should be noted that the physician did not use a rotating hemostasis valve (rhv) but did maintain a continuous flush throughout the procedure.In addition, the catheter was flushed after each coil insertion.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: 6080266
• Report Number: 3005168196-2016-01567
• Device Sequence Number: 1136562
• Product Code: HCG
• UDI-Device Identifier: 00814548010885
• UDI-Public: 00814548010885
• 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): 10/07/2016

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: 06/25/2024
• Device Catalogue Number: 4004C0615
• Device Lot Number: F70325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2016
• Initial Report FDA Received Date: 11/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1