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

Catalog Number RBYPODJ60

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-01773.

Event Description

The patient was undergoing a coil embolization procedure in the internal thoracic artery using pod packing coils (pod pc).During the procedure, the physician placed a pod pc and another coil in the target vessel using a non-penumbra microcatheter.While advancing a new pod pc, the physician experienced resistance at the hub of the microcatheter and, therefore, it was removed.The physician then advanced a new pod pc, however, while advancing and retracting the pod pc within its introducer sheath, it detached.Therefore, the physician successfully removed the introducer sheath containing the detached pod pc.The procedure was completed using additional pod pcs, 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 pod packing coil (pod pc) pusher assembly.The pusher assembly was kinked approximately 5.0, 30.0, 39.5, and 49.0 cm from its proximal end.The embolization coil was detached from its pusher assembly inside its introducer sheath and the coil had offset coil wind.Conclusions: evaluation of the first returned pod pc revealed that the embolization coil had offset coil winds.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, resistance may be experienced.Forceful advancement against resistance may result in offset coil winds.Further evaluation of the returned pod pc revealed that the introducer sheath had coagulated blood inside the sheath and the pusher assembly was kinked.The coagulated blood inside the sheath likely contributed to the inability to advance and retract the pod pc within its introducer sheath.The kinks on the pusher assembly were likely incidental to the reported complaint.Evaluation of the second returned pod pc confirmed that the embolization coil was detached from its pusher assembly.If the pod pc is forcefully retracted against resistance, the pusher assembly may elongate beyond the reach of its pull wire, allowing the proximal constraint sphere to be released the ddt.This will result in the coil detaching from its pusher assembly.Further evaluation of the returned ruby coil revealed pusher assembly kinks and offset coil winds on the embolization coil.These kinks and ovalizations were likely incidental to the reported complaint.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: 3005168196-2019-01773.

• Brand Name: POD PACKING COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9082791
• MDR Text Key: 159027604
• Report Number: 3005168196-2019-01774
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017679
• UDI-Public: 00814548017679
• Combination Product (y/n): Y
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/21/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: RBYPODJ60
• Device Lot Number: F90477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 11/07/2019
• Supplement Dates FDA Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 15