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

Catalog Number	4004C1030
Medical Device Problem Codes	Retraction Problem (1536); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2017
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 the pusher assembly and had offset coil winds in multiple locations throughout its length.Conclusion: evaluation of the returned device revealed the pc400 embolization coil had offset coil winds in multiple locations throughout its length.These offset coil winds caused resistance when attempting to retract and advance the embolization coil through its introducer sheath during functional analysis.Offset coil winds typically occur due to forceful advancement of the pc400 against resistance.The root cause of the initial resistance could not be determined.Penumbra coils 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.
Event or Problem Description
The patient was undergoing a coil embolization to treat a pulmonary arteriovenous fistula (p-avf) using a penumbra coil 400 (pc400).During the procedure, the physician advanced the microcatheter toward the treatment site.Prior to inserting a pc400 in the microcatheter, the physician attempted to advance the coil out of its introducer sheath on the back table; however, resistance was encountered as the coil was being advanced out of its introducer sheath.The physician decided to retract the pc400 back into its introducer sheath; however, the pc400 was entrapped and would not retract.Therefore, the pc400 was set aside and the procedure was completed using a new pc400 without further issues.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: 6914143
• Report Number: 3005168196-2017-01718
• Device Sequence Number: 1312684
• Product Code: HCG
• UDI-Device Identifier: 00814548010977
• UDI-Public: 00814548010977
• 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: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2017

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: 03/14/2025
• Device Catalogue Number: 4004C1030
• Device Lot Number: F75029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2017
• Initial Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR