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

Catalog Number RBYPODJ60

Device Problems Physical Resistance (2578); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2018-01171.

Event Description

The patient was undergoing a coil embolization procedure using pod packing coils (podj¿s).During the procedure, the physician placed a pod5 in the target vessel using a non-penumbra microcatheter.While attempting to place podj in the target vessel, the microcatheter kicked back because the lumen of the aneurysm sac was large.Therefore, the physician decided to remove the podj in order to reposition the microcatheter; however, the podj would not re-sheath.Therefore, the physician pulled the podj out of the microcatheter and upon removal, a knot was noticed in the middle of the coil.The podj was set aside and a new podj was opened.While advancing the new podj through the microcatheter, the physician experienced resistance and podj became stuck inside the microcatheter; therefore, it was removed.The procedure was completed using completed using other coils and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 5.0 cm from the proximal end of the pusher assembly.The embolization coil was intact with the pusher assembly.The embolization coil had offset coil winds.Bends were present through the length of the device.Coagulated blood was present within the introducer sheath.The podj was hydrated and was able to be advanced out of its introducer sheath.The podj was able to be advanced out of a demonstration microcatheter.Conclusions: evaluation of the first podj confirmed a knot was present in the embolization coil.The complaint reported that the microcatheter kicked back due to the large size of the aneurysm.If the microcatheter experiences kick back it may cause the embolization coil to interact with itself in an unexpected way.The embolization coil was not knotted when it was advanced through the catheter and the microcatheter kicking back likely contributed to the knot forming.The knotting of the embolization coil likely resulted in the experienced inability to re-sheath the device.During functional testing the embolization coil was able to be unknotted, however it was unable to be retracted into its introducer sheath due to coagulated blood within the introducer sheath.Evaluation of the second podj revealed the embolization coil had offset coil winds along its length.If the device is advanced against resistance, damage such as offset coil winds may occur.Evaluation of the returned non-penumbra microcatheter revealed that it was ovalized on its midshaft.This ovalization likely contributed to the resistance experienced when advancing the podj and the offset coil winds.During functional testing, the podj was able to be advanced through the length of a demonstration catheter.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.This report is associated with mfr report number: 3005168196-2018-01171.

• Brand Name: POD PACKING COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7597512
• MDR Text Key: 111015171
• Report Number: 3005168196-2018-01172
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016733
• UDI-Public: 00814548016733
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBYPODJ60
• Device Lot Number: C03406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR