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

Catalog Number	4002C1245
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	05/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a pulmonary arteriovenous fistula (p-avf) using penumbra coils 400 (pc400¿s).During the procedure, the physician placed two non-penumbra coils and five pc400¿s in the target vessel using a non-penumbra microcatheter.While attempting to advance new pc400 into the microcatheter, the physician experienced resistance and the pc400 would not advance out of the distal tip of its introducer sheath; therefore, it was removed.The procedure was completed using additional pc400¿s, other coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the proximal pet lock was intact.The pusher assembly was bent approximately 47.0 cm and 69.0 cm from the proximal end of the pusher.The embolization coil was intact with the pusher assembly.The embolization coil was undamaged.The introducer sheath was ovalized approximately 8.5 cm from the distal end of the sheath.During functional testing, resistance was encountered at the ovalized location on the sheath while attempting to advance the coil distally and the coil was unable to advance any further.Conclusions: evaluation of the returned pc400 revealed that the introducer sheath was ovalized on its distal end.This damage can result due to mishandling during preparation or possibly the overtightening of the rhv onto the introducer sheath.This ovalization likely contributed to the reported resistance during the procedure and during functional testing.The non-penumbra microcatheter identified in the complaint was not returned for evaluation.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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7589694
• Report Number: 3005168196-2018-01151
• Device Sequence Number: 11318245
• Product Code: HCG
• UDI-Device Identifier: 00814548010649
• UDI-Public: 00814548010649
• Combination Product (Y/N): Y
• 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,Followup
• Report Date (Section B): 05/15/2018
• Report Date (Section F): 01/01/2005

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: 06/21/2024
• Device Catalogue Number: 4002C1245
• Device Lot Number: F70269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005