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

Catalog Number	4004C0820
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The embolization coil was intact with its pusher assembly.The embolization coil windings were offset along the length of the coil inside the introducer sheath.The distal tip of the introducer sheath had coagulated blood around the distal tip of the embolization coil.Conclusions: evaluation of the returned device revealed that the pc400 embolization coil windings were offset and the distal tip of the embolization coil had coagulated blood around it inside the introducer sheath.The offset coil winding damage likely occurred as a result of repeated forceful attempts to advance or withdraw the pc400, and likely contributed to the resistance experienced while advancing the pc400 out of its introducer sheath.Further evaluation of the returned devices revealed that the distal tip of the embolization coil inside the introducer sheath had coagulated blood around it.Although the initial complaint indicated that the device did not come into contact with the patient, coagulated blood was found inside the introducer sheath, indicating that the device may have had contact with the patient.The root cause of the blood inside the introducer sheath could not be determined; however, the coagulated blood at the distal end of the introducer sheath may have also contributed to the reported issue.Penumbra coils are visually 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.
Event or Problem Description
Prior to advancing a penumbra coil 400 (pc400) through the non-penumbra microcatheter and into the patient, the physician wanted to make sure that the pc400 was working properly and attempted to advance the coil out of its introducer sheath; however, resistance was encountered and the tip of the coil was unable to exit the introducer sheath.Therefore, the pc400 was set aside and did not come into contact with the patient.The procedure was successfully completed using a total of (b)(4) pc400's.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6811348
• Report Number: 3005168196-2017-01403
• Device Sequence Number: 16393626
• Product Code: HCG
• UDI-Device Identifier: 00814548010922
• UDI-Public: 00814548010922
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2017

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: 02/19/2025
• Device Catalogue Number: 4004C0820
• Device Lot Number: F74521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1