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

Catalog Number	RBYPODJ15
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2018
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 in a pulmonary vein using a pod packing coil (podj).During the procedure, the physician advanced a podj into the target vessel using a lantern delivery microcatheter (lantern).The physician then retracted the podj in order to reposition the lantern; however, the last five centimeters of the podj became stuck in the introducer sheath while being re-sheathed.Therefore, the podj was removed and the procedure was completed using another coil and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 5.0, 53.0, 72.0, and 95.0 cm from the proximal end.The embolization coil was intact with its pusher assembly and the introducer sheath had coagulated blood inside.Resistance was encountered while attempting to advance the embolization coil out of its sheath as the embolization coil met the coagulated blood inside the introducer sheath.The podj could not be advanced out of its sheath and, therefore, could not be functionally tested with a demonstration microcatheter.Conclusions: evaluation of the returned podj revealed that the introducer sheath had coagulated blood inside it.During the functional test, resistance was encountered while attempting to advance the embolization coil out of its introducer sheath as the embolization coil met the coagulated blood inside the introducer sheath.The root cause of the last five centimeters of the podj getting stuck in the introducer sheath while being re-sheath could not be determined.The embolization coil was returned completely re-sheathed.The lantern identified in the complaint was not returned to penumbra for evaluation.Penumbra coils and catheters 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.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7494790
• Report Number: 3005168196-2018-00963
• Device Sequence Number: 13879299
• Product Code: HCG
• UDI-Device Identifier: 00814548016702
• UDI-Public: 00814548016702
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018
• 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: 12/26/2025
• Device Catalogue Number: RBYPODJ15
• Device Lot Number: F81190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Date Report Sent to FDA: 01/01/2005